Clincosm LogoSign in Get a demo

Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer

Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00609622
Collaborator
(none)
191
Enrollment
97
Locations
2
Arms
39
Duration (Months)
2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will compare the safety and efficacy of sunitinib in combination with FOLFOX versus bevacizumab in combination with FOLFOX for the treatment of patients with metastatic colorectal cancer who have not been treated before.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

The study was terminated on April 26, 2010 due to lack of efficacy, as determined during the interim analysis of data in April 2010, showing that the study did not meet its primary endpoint to demonstrate a statistically significant improvement in PFS. The decision to terminate the trial was not based on any safety concerns.

Study Design

Study Type:
Interventional
Actual Enrollment :
191 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Phase 2B Study Of Sunitinib Plus Oxaliplatin, 5-Fluorouracil And Leucovorin (FOLFOX) Versus Bevacizumab Plus FOLFOX As First-Line Treatment In Patients With Metastatic Colorectal Cancer
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Treatment arm A - sunitinib plus mFOLFOX6

Drug: sunitinib
Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2).
Other Names:
  • Sutent, SU011248

    • Drug: mFOLFOX6
    FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m^2 + leucovorin 400 mg/ m^2 (or 200 mg/ m^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle
    Active Comparator: B

    Treatment arm B - bevacizumab plus mFOLFOX6

    Drug: bevacizumab
    Bevacizumab: 5 mg/kg, IV infusion, every 2 weeks.
    Other Names:
  • Avastin

    • Drug: mFOLFOX6
    FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m^2 + leucovorin 400 mg/ m^2 (or 200 mg/ m^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival (PFS) [Baseline, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115)]

      Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").

    Secondary Outcome Measures

    1. Overall Survival (OS) [Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to Week 115)]

      Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

    2. One Year Survival Probability [Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 1 year)]

      One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.

    3. Two Year Survival Probability [Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 2 years)]

      Two year survival probability was defined as the probability of survival at two years after the first dose of study treatment.

    4. Percentage of Participants With Objective Response (OR) [Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115]

      Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.

    5. Duration of Response (DR) [Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115]

      Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

    6. Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score [Baseline [Day (D) 1 of Cycle (C) 1] then every 3 cycles thereafter and at the end of treatment (EOT) or withdrawal visit (up to Week 115)]

      FACT-C used for assessment of health-related quality of life (QoL) in participants with cancer. It consists of 36 items, summarized to 5 subscales:physical well-being (PWB) (7 items), functional well-being (FWB) (7 items), social/family well-being (SWB) (7 items); all 3 subscales range from 0 to 28, emotional well-being (EWB) (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL.

    7. Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score [Baseline (D1 of C1) then every 3 cycles thereafter and at the EOT or withdrawal visit (up to 115 weeks)]

      FACT&GOG-Ntx has a 13-item, treatment-specific subscale for patients with neurotoxicity. It is the sum of the PWB (7 items), FWB (7 items), SWB (7 items) and EWB (6 items) subscales plus a 13 item neurotoxicity subscale. Subscale score ranges from 0 to 28 for PWB, FWB, SWB, 0 to 24 for EWB and 0 to 52 for neurotoxicity subscale. Total possible score range is 0 to 160. Higher scores indicates better QoL, fewer disease symptoms, and/or fewer side effects of treatment and lower scores indicate worse QoL and a greater impact of disease symptoms and/or side effects.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adenocarcinoma of the colon or rectum with locally advanced or metastatic disease

    • Evidence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)

    • Eastern Cooperative Oncology Group (ECOG) 0 or 1

    Exclusion Criteria:

    • Previous treatment with Sutent, Avastin, or any other systemic therapy for locally advanced or metastatic colorectal cancer

    • Less than 6 months since completion of adjuvant chemotherapy to documentation of recurrent disease

    • History of cardiac disease

    • Brain mets

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Fairhope Alabama United States 36532
    2 Pfizer Investigational Site Mobile Alabama United States 36604
    3 Pfizer Investigational Site Chandler Arizona United States 85224
    4 Pfizer Investigational Site Mesa Arizona United States 85206
    5 Pfizer Investigational Site Bentonville Arkansas United States 72712
    6 Pfizer Investigational Site Fayetteville Arkansas United States 72703
    7 Pfizer Investigational Site Hot Springs Arkansas United States 71913
    8 Pfizer Investigational Site Bakersfield California United States 93309
    9 Pfizer Investigational Site Fresno California United States 93720
    10 Pfizer Investigational Site Fullerton California United States 92835
    11 Pfizer Investigational Site Lancaster California United States 93534
    12 Pfizer Investigational Site Los Angeles California United States 90095-1772
    13 Pfizer Investigational Site Los Angeles California United States 90095-6984
    14 Pfizer Investigational Site Los Angeles California United States 90095
    15 Pfizer Investigational Site Mission Hills California United States 91345
    16 Pfizer Investigational Site Northrige California United States 91325
    17 Pfizer Investigational Site Oxnard California United States 93030
    18 Pfizer Investigational Site Pasadena California United States 91105
    19 Pfizer Investigational Site Redondo Beach California United States 90277
    20 Pfizer Investigational Site Santa Barbara California United States 93105
    21 Pfizer Investigational Site Santa Maria California United States 93454
    22 Pfizer Investigational Site Santa Monica California United States 90404
    23 Pfizer Investigational Site Solvang California United States 93436
    24 Pfizer Investigational Site Valencia California United States 91355
    25 Pfizer Investigational Site Aurora Colorado United States 80045
    26 Pfizer Investigational Site Washington District of Columbia United States 20007
    27 Pfizer Investigational Site Gainesville Florida United States 32605
    28 Pfizer Investigational Site Jacksonville Beach Florida United States 32250
    29 Pfizer Investigational Site Jacksonville Florida United States 32204
    30 Pfizer Investigational Site Jacksonville Florida United States 32207
    31 Pfizer Investigational Site Jacksonville Florida United States 32258
    32 Pfizer Investigational Site Jasonville Florida United States 32207
    33 Pfizer Investigational Site Orange Park Florida United States 32073
    34 Pfizer Investigational Site Palatka Florida United States 32177
    35 Pfizer Investigational Site St. Augustine Florida United States 32086
    36 Pfizer Investigational Site Stuart Florida United States 34994
    37 Pfizer Investigational Site Atlanta Georgia United States 30341
    38 Pfizer Investigational Site Decatur Georgia United States 30033
    39 Pfizer Investigational Site Macon Georgia United States 31217
    40 Pfizer Investigational Site Marietta Georgia United States 30060
    41 Pfizer Investigational Site Sandy Springs Georgia United States 30342
    42 Pfizer Investigational Site Maryville Illinois United States 62062
    43 Pfizer Investigational Site Chanute Kansas United States 66720
    44 Pfizer Investigational Site Dodge City Kansas United States 67801
    45 Pfizer Investigational Site El Dorado Kansas United States 67042
    46 Pfizer Investigational Site Independence Kansas United States 67301
    47 Pfizer Investigational Site Kingman Kansas United States 67068
    48 Pfizer Investigational Site Liberal Kansas United States 67905
    49 Pfizer Investigational Site Newton Kansas United States 67114
    50 Pfizer Investigational Site Parsons Kansas United States 67357
    51 Pfizer Investigational Site Salina Kansas United States 67401
    52 Pfizer Investigational Site Wellington Kansas United States 67152
    53 Pfizer Investigational Site Wichita Kansas United States 67208
    54 Pfizer Investigational Site Wichita Kansas United States 67214
    55 Pfizer Investigational Site Winfield Kansas United States 67156
    56 Pfizer Investigational Site Baltimore Maryland United States 21225
    57 Pfizer Investigational Site Baltimore Maryland United States 21237
    58 Pfizer Investigational Site Columbus Mississippi United States 39705
    59 Pfizer Investigational Site Corinth Mississippi United States 38834
    60 Pfizer Investigational Site Tupelo Mississippi United States 38801
    61 Pfizer Investigational Site Columbia Missouri United States 65203
    62 Pfizer Investigational Site Henderson Nevada United States 89052
    63 Pfizer Investigational Site Las Vegas Nevada United States 89128
    64 Pfizer Investigational Site Las Vegas Nevada United States 89148
    65 Pfizer Investigational Site Las Vegas Nevada United States 89169
    66 Pfizer Investigational Site Norman Oklahoma United States 73071
    67 Pfizer Investigational Site Oklahoma City Oklahoma United States 73102
    68 Pfizer Investigational Site Oklahoma City Oklahoma United States 73109
    69 Pfizer Investigational Site Oklahoma City Oklahoma United States 73120
    70 Pfizer Investigational Site Tulsa Oklahoma United States 74104
    71 Pfizer Investigational Site Tulsa Oklahoma United States 74133
    72 Pfizer Investigational Site Tulsa Oklahoma United States 74136
    73 Pfizer Investigational Site Portland Oregon United States 97227
    74 Pfizer Investigational Site Meadowbrook Pennsylvania United States 19046
    75 Pfizer Investigational Site Philadelphia Pennsylvania United States 19106
    76 Pfizer Investigational Site Philadelphia Pennsylvania United States 19107
    77 Pfizer Investigational Site Radnor Pennsylvania United States 19087
    78 Pfizer Investigational Site Willow Grove Pennsylvania United States 19090
    79 Pfizer Investigational Site Beaumont Texas United States 77701
    80 Pfizer Investigational Site Lubbock Texas United States 79415
    81 Pfizer Investigational Site Wenatchee Washington United States 98801
    82 Pfizer Investigational Site Aalborg Denmark 9100
    83 Pfizer Investigational Site Herlev Denmark 2730
    84 Pfizer Investigational Site Koebenhavn OE Denmark 2100
    85 Pfizer Investigational Site Aschaffenburg Germany 63739
    86 Pfizer Investigational Site Bad Saarow Germany 15526
    87 Pfizer Investigational Site Berlin Germany 13125
    88 Pfizer Investigational Site Duesseldorf Germany 40225
    89 Pfizer Investigational Site Magdeburg Germany 39104
    90 Pfizer Investigational Site Mainz Germany 55131
    91 Pfizer Investigational Site Regensburg Germany 93053
    92 Pfizer Investigational Site Kashiwa Chiba Japan
    93 Pfizer Investigational Site Sapporo Hokkaido Japan
    94 Pfizer Investigational Site Kitaadachi-gun, Ina-cho Saitama Japan
    95 Pfizer Investigational Site Suntougun Shizuoka Japan
    96 Pfizer Investigational Site Utsunomiya Tochigi Japan
    97 Pfizer Investigational Site Chuo-ku Tokyo Japan

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00609622
    Other Study ID Numbers:
    • A6181104
    First Posted:
    Feb 7, 2008
    Last Update Posted:
    Oct 11, 2012
    Last Verified:
    Sep 1, 2012
    Keywords provided by Pfizer
    metastatic colorectal cancer sunitinib (Sutent) bevacizumab (Avastin) randomized study
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Bevacizumab
    Sunitinib

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
    Arm/Group Description Sunitinib 37.5 milligram (mg) capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, lecovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg per square meter (mg/m^2) and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour intravenous (IV) infusion followed by an IV bolus of 5-fluorouracil (5-FU) 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle. Bevacizumab 5 mg/kilogram (mg/kg) administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and a 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
    Period Title: Overall Study
    STARTED 96 95
    COMPLETED 0 0
    NOT COMPLETED 96 95

    Baseline Characteristics

    Arm/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6 Total
    Arm/Group Description Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle. Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle. Total of all reporting groups
    Overall Participants 96 95 191
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    60.60
    (9.26)
    59.10
    (10.81)
    59.90
    (10.06)
    Sex: Female, Male (Count of Participants)
    Female
    35
    36.5%
    33
    34.7%
    68
    35.6%
    Male
    61
    63.5%
    62
    65.3%
    123
    64.4%

    Outcome Measures

    1. Primary Outcome
    Title Progression-free Survival (PFS)
    Description Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
    Time Frame Baseline, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115)

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis (FA) set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.
    Arm/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
    Arm/Group Description Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle. Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
    Measure Participants 96 95
    Median (95% Confidence Interval) [Weeks]
    40.50
    67.00
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments P-value was calculated from a 1-sided, log-rank test stratified for Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), Baseline Lactate Dehydrogenase (LDH): greater than (>) 1.5 vs. less than or equal to (<=) 1.5 * upper limit of normal range (ULN), and Prior Adjuvant Treatment (yes vs. no).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9963
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 2.705
    Confidence Interval (2-Sided) 95%
    1.272 to 5.751
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Overall Survival (OS)
    Description Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
    Time Frame Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to Week 115)

    Outcome Measure Data

    Analysis Population Description
    The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.
    Arm/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
    Arm/Group Description Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle. Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
    Measure Participants 96 95
    Median (95% Confidence Interval) [Weeks]
    84.30
    NA
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments P-value was calculated from a 1-sided, log-rank test stratified for ECOG Performance Status (0 vs. 1), Baseline LDH: >1.5 vs. <=1.5 * ULN, and Prior Adjuvant Treatment (yes vs. no).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9289
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.618
    Confidence Interval (2-Sided) 95%
    0.845 to 3.096
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title One Year Survival Probability
    Description One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.
    Time Frame Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 1 year)

    Outcome Measure Data

    Analysis Population Description
    Data was not analyzed due to early study termination.
    Arm/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
    Arm/Group Description Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle. Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
    Measure Participants 0 0
    4. Secondary Outcome
    Title Two Year Survival Probability
    Description Two year survival probability was defined as the probability of survival at two years after the first dose of study treatment.
    Time Frame Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 2 years)

    Outcome Measure Data

    Analysis Population Description
    Data was not analyzed due to early study termination.
    Arm/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
    Arm/Group Description Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle. Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
    Measure Participants 0 0
    5. Secondary Outcome
    Title Percentage of Participants With Objective Response (OR)
    Description Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
    Time Frame Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115

    Outcome Measure Data

    Analysis Population Description
    The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.
    Arm/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
    Arm/Group Description Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle. Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
    Measure Participants 96 95
    Number (95% Confidence Interval) [Percentage of participants]
    41.70
    43.4%
    37.90
    39.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5898
    Comments
    Method Chi-squared
    Comments
    Method of Estimation Estimation Parameter F-Distribution
    Estimated Value 3.956
    Confidence Interval (2-Sided) 95%
    -10.412 to 18.324
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Duration of Response (DR)
    Description Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
    Time Frame Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115

    Outcome Measure Data

    Analysis Population Description
    Data was not analyzed due to early study termination.
    Arm/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
    Arm/Group Description Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle. Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
    Measure Participants 0 0
    7. Secondary Outcome
    Title Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score
    Description FACT-C used for assessment of health-related quality of life (QoL) in participants with cancer. It consists of 36 items, summarized to 5 subscales:physical well-being (PWB) (7 items), functional well-being (FWB) (7 items), social/family well-being (SWB) (7 items); all 3 subscales range from 0 to 28, emotional well-being (EWB) (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL.
    Time Frame Baseline [Day (D) 1 of Cycle (C) 1] then every 3 cycles thereafter and at the end of treatment (EOT) or withdrawal visit (up to Week 115)

    Outcome Measure Data

    Analysis Population Description
    FA set included participants randomized with study drug assignment, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. Here "n" signifies those participants evaluated for this measure at specific time point for each cohort respectively.
    Arm/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
    Arm/Group Description Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle. Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
    Measure Participants 96 95
    PWB Baseline (n= 93, 90)
    23.21
    (4.108)
    23.29
    (4.324)
    PWB Change at C4 D1 (n=80, 82)
    -2.65
    (4.132)
    -1.24
    (4.930)
    PWB Change at C7 D1 (n=59, 75)
    -3.39
    (5.532)
    -1.94
    (4.217)
    PWB Change at C10 D1 (n=45, 62)
    -3.66
    (4.732)
    -1.85
    (4.690)
    PWB Change at C13 D1 (n=34, 40)
    -3.88
    (4.969)
    -2.24
    (4.364)
    PWB Change at C16 D1 (n=25, 32)
    -3.88
    (4.850)
    -2.83
    (4.937)
    PWB Change at C19 D1 (n=13, 23)
    -3.46
    (4.977)
    -1.49
    (4.308)
    PWB Change at C22 D1 (n=6, 20)
    -1.67
    (4.885)
    -2.08
    (3.429)
    PWB Change at C25 D1 (n=1, 15)
    7.00
    (NA)
    -1.90
    (3.762)
    PWB Change at C28 D1 (n=1, 10)
    4.0
    (NA)
    -1.6
    (5.15)
    PWB Change at C31 D1 (n=1, 4)
    3.0
    (NA)
    -2.8
    (6.18)
    PWB Change at C34 D1 (n=1, 1)
    6.0
    (NA)
    0.0
    (NA)
    PWB Change at C37 D1 (n=0, 1)
    NA
    (NA)
    0.0
    (NA)
    PWB Change at C40 D1 (n=0, 1)
    NA
    (NA)
    0.0
    (NA)
    PWB Change at C43 D1 (n=0, 1)
    NA
    (NA)
    0.0
    (NA)
    PWB Change at C46 D1 (n=0, 1)
    NA
    (NA)
    0.0
    (NA)
    PWB Change at C49 D1 (n=0, 1)
    NA
    (NA)
    0.0
    (NA)
    PWB Change at EOT (n=57, 43)
    -4.16
    (4.686)
    -3.52
    (6.222)
    SWB Baseline (n=93, 88)
    23.42
    (4.679)
    23.16
    (4.442)
    SWB Change at C4 D1 (n=80, 81)
    0.03
    (3.129)
    0.31
    (3.823)
    SWB Change at C7 D1 (n=59, 73)
    -0.24
    (3.941)
    0.27
    (3.931)
    SWB Change at C10 D1 (n=45, 60)
    -0.89
    (3.781)
    0.05
    (3.753)
    SWB Change at C13 D1 (n=34, 39)
    -0.24
    (2.486)
    -1.33
    (4.278)
    SWB Change at C16 D1 (n=25, 31)
    -0.64
    (3.369)
    -1.24
    (4.415)
    SWB Change at C19 D1 (n=13, 23)
    -0.79
    (2.024)
    -1.47
    (4.751)
    SWB Change at C22 D1 (n=6, 20)
    -0.67
    (2.065)
    -1.18
    (3.787)
    SWB Change at C25 D1 (n=1, 15)
    -4.00
    (NA)
    -0.06
    (4.191)
    SWB Change at C28 D1 (n=1, 10)
    -3.50
    (NA)
    -0.65
    (4.627)
    SWB Change at C31 D1 (n=1, 4)
    -4.00
    (NA)
    3.58
    (3.233)
    SWB Change at C34 D1 (n=1, 1)
    -3.50
    (NA)
    1.00
    (NA)
    SWB Change at C37 D1 (n=0, 1)
    NA
    (NA)
    1.0
    (NA)
    SWB Change at C 40 D1 (n=0, 1)
    NA
    (NA)
    0.0
    (NA)
    SWB Change at C43 D1 (n=0, 1)
    NA
    (NA)
    0.0
    (NA)
    SWB Change at C46 D1 (n=0, 1)
    NA
    (NA)
    0.0
    (NA)
    SWB Change at C49 D1 (n=0, 1)
    NA
    (NA)
    0.0
    (NA)
    SWB Change at EOT (n=57, 43)
    -0.35
    (3.501)
    -0.63
    (2.902)
    EWB Baseline (n=93, 90)
    16.74
    (4.342)
    17.30
    (3.995)
    EWB Change at C4 D1 (n=80, 82)
    0.95
    (3.505)
    1.40
    (4.108)
    EWB Change at C7 D1 (n=59, 75)
    1.65
    (3.108)
    1.71
    (4.036)
    EWB Change at C10 D1 (n=45, 62)
    1.40
    (4.014)
    1.65
    (4.121)
    EWB Change at C13 D1 (n=34, 40)
    1.3
    (4.45)
    1.4
    (4.30)
    EWB Change at C16 D1 (n=25, 32)
    0.84
    (3.934)
    0.96
    (4.511)
    EWB Change at C19 D1 (n=13, 23)
    1.2
    (2.92)
    1.8
    (4.56)
    EWB Change at C22 D1 (n=6, 20)
    0.2
    (3.66)
    1.1
    (3.39)
    EWB Change at C25 D1 (n=1, 15)
    4.0
    (NA)
    -0.3
    (5.32)
    EWB Change at C28 D1 (n=1, 10)
    4.0
    (NA)
    0.1
    (3.45)
    EWB Change at C31 D1 (n=1, 4)
    2.0
    (NA)
    2.3
    (4.50)
    EWB Change at C34 D1 (n=1, 1)
    4.0
    (NA)
    0.0
    (NA)
    EWB Change at C37 D1 (n=0, 1)
    NA
    (NA)
    0.0
    (NA)
    EWB Change at C40 D1 (n=0, 1)
    NA
    (NA)
    1.0
    (NA)
    EWB Change at C43 D1 (n=0, 1)
    NA
    (NA)
    1.0
    (NA)
    EWB Change at C46 D1 (n=0, 1)
    NA
    (NA)
    1.0
    (NA)
    EWB Change at C49 D1 (n=0, 1)
    NA
    (NA)
    1.0
    (NA)
    EWB Change at EOT (n=57, 43)
    0.35
    (4.805)
    0.77
    (4.942)
    FWB Baseline (n=93, 89)
    17.88
    (5.818)
    17.29
    (6.328)
    FWB Change at C4 D1 (n=80, 81)
    -0.78
    (5.007)
    1.56
    (5.536)
    FWB Change at C7 D1 (n=59, 74)
    -0.02
    (5.425)
    1.02
    (5.493)
    FWB Change at C10 D1 (n=45, 61)
    -0.35
    (4.471)
    0.74
    (5.884)
    FWB Change at C13 D1 (n=34, 40)
    -0.4
    (5.02)
    0.8
    (5.88)
    FWB Change at C16 D1 (n=24, 31)
    -0.7
    (3.65)
    -0.7
    (4.95)
    FWB Change at C19 D1 (n=13, 22)
    -0.3
    (3.88)
    0.1
    (6.11)
    FWB Change at C22 D1 (n=6, 19)
    0.7
    (6.35)
    -0.8
    (4.72)
    FWB Change at C25 D1 (n=1, 14)
    12.0
    (NA)
    -1.0
    (4.40)
    FWB Change at C28 D1 (n=1, 9)
    13.0
    (NA)
    -0.8
    (4.74)
    FWB Change at C31 D1 (n=1, 3)
    6.0
    (NA)
    1.0
    (3.61)
    FWB Change at C34 D1 (n=1, 1)
    12.0
    (NA)
    0.0
    (NA)
    FWB Change at C37 D1 (n=0, 1)
    NA
    (NA)
    0.0
    (NA)
    FWB Change at C40 D1 (n=0, 1)
    NA
    (NA)
    -3.0
    (NA)
    FWB Change at C43 D1 (n=0, 1)
    NA
    (NA)
    -3.0
    (NA)
    FWB Change at C46 D1 (n=0, 1)
    NA
    (NA)
    -3.0
    (NA)
    FWB Change at C49 D1 (n=0, 1)
    NA
    (NA)
    -3.0
    (NA)
    FWB Change at EOT (n=56, 43)
    1.62
    (5.394)
    0.14
    (6.075)
    CCS Baseline (n=93, 90)
    20.93
    (4.733)
    21.26
    (5.064)
    CCS Change at C4 D1 (n=78, 82)
    -1.49
    (4.228)
    -0.13
    (4.485)
    CCS Change at C7 D1 (n=60, 75)
    -1.00
    (5.193)
    -0.26
    (4.726)
    CCS Change at C10 D1 (n=45, 62)
    -1.03
    (4.859)
    -0.16
    (5.474)
    CCS Change at C13 D1 (n=34, 40)
    -1.33
    (5.224)
    -0.20
    (5.105)
    CCS Change at C16 D1 (n=25, 32)
    -1.32
    (4.425)
    -1.25
    (5.086)
    CCS Change at C19 D1 (n=13, 23)
    -2.13
    (4.732)
    -0.36
    (4.754)
    CCS Change at C22 D1 (n=6, 20)
    -0.92
    (5.219)
    0.15
    (3.815)
    CCS Change at C25 D1 (n=1, 15)
    1.0
    (NA)
    1.3
    (5.55)
    CCS Change at C28 D1 (n=1, 10)
    -2.0
    (NA)
    0.4
    (5.46)
    CCS Change at C31 D1 (n=1, 4)
    -2.0
    (NA)
    1.8
    (4.35)
    CCS Change at C34 D1 (n=1, 1)
    -1.0
    (NA)
    0.0
    (NA)
    CCS Change at C37 D1 (n=0, 1)
    NA
    (NA)
    0.0
    (NA)
    CCS Change at C40 D1 (n=0, 1)
    NA
    (NA)
    -1.0
    (NA)
    CCS Change at C43 D1 (n=0, 1)
    NA
    (NA)
    -1.0
    (NA)
    CCS Change at C46 D1 (n=0, 1)
    NA
    (NA)
    0.0
    (NA)
    CCS Change at C49 D1 (n=0, 1)
    NA
    (NA)
    0.0
    (NA)
    CCS Change at EOT (n=55, 43)
    -1.06
    (4.942)
    -0.48
    (5.679)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in PWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0515
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -1.40
    Confidence Interval (2-Sided) 95%
    -2.82 to 0.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in PWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0876
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -1.45
    Confidence Interval (2-Sided) 95%
    -3.11 to 0.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in PWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0522
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -1.81
    Confidence Interval (2-Sided) 95%
    -3.64 to 0.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in PWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1339
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -1.64
    Confidence Interval (2-Sided) 95%
    -3.81 to 0.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in PWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4233
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -1.05
    Confidence Interval (2-Sided) 95%
    -3.68 to 1.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in PWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2211
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -1.97
    Confidence Interval (2-Sided) 95%
    -5.18 to 1.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in PWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8184
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.41
    Confidence Interval (2-Sided) 95%
    -3.22 to 4.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in PWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0380
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 8.90
    Confidence Interval (2-Sided) 95%
    0.57 to 17.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in PWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3266
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 5.60
    Confidence Interval (2-Sided) 95%
    -6.61 to 17.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in PWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4667
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 5.75
    Confidence Interval (2-Sided) 95%
    -16.26 to 27.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in PWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0
    Confidence Interval (2-Sided) 95%
    0 to 0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in PWB between treatment arms (EOT) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5587
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.64
    Confidence Interval (2-Sided) 95%
    -2.80 to 1.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in SWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6122
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.28
    Confidence Interval (2-Sided) 95%
    -1.37 to 0.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in SWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4642
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.51
    Confidence Interval (2-Sided) 95%
    -1.87 to 0.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in SWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2105
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.94
    Confidence Interval (2-Sided) 95%
    -2.41 to 0.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in SWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1950
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 1.09
    Confidence Interval (2-Sided) 95%
    -0.57 to 2.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in SWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5779
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.60
    Confidence Interval (2-Sided) 95%
    -1.55 to 2.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in SWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6314
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.67
    Confidence Interval (2-Sided) 95%
    -2.15 to 3.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in SWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7554
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.51
    Confidence Interval (2-Sided) 95%
    -2.85 to 3.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in SWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3781
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -3.94
    Confidence Interval (2-Sided) 95%
    -13.22 to 5.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in SWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5715
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -2.85
    Confidence Interval (2-Sided) 95%
    -13.83 to 8.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in SWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1271
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -7.58
    Confidence Interval (2-Sided) 95%
    -19.08 to 3.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in SWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0
    Confidence Interval (2-Sided) 95%
    0 to 0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in SWB between treatment arms (EOT) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6785
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.27
    Confidence Interval (2-Sided) 95%
    -1.03 to 1.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in EWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4623
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.44
    Confidence Interval (2-Sided) 95%
    -1.63 to 0.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in EWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9302
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.06
    Confidence Interval (2-Sided) 95%
    -1.31 to 1.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in EWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7502
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.25
    Confidence Interval (2-Sided) 95%
    -1.84 to 1.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in EWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9335
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.09
    Confidence Interval (2-Sided) 95%
    -2.12 to 1.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in EWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9191
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.12
    Confidence Interval (2-Sided) 95%
    -2.40 to 2.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in EWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6750
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.60
    Confidence Interval (2-Sided) 95%
    -3.46 to 2.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in EWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5874
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.88
    Confidence Interval (2-Sided) 95%
    -4.20 to 2.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in EWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4507
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 4.27
    Confidence Interval (2-Sided) 95%
    -7.53 to 16.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in EWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3087
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 3.90
    Confidence Interval (2-Sided) 95%
    -4.28 to 12.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in EWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9635
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.25
    Confidence Interval (2-Sided) 95%
    -16.26 to 15.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in EWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0
    Confidence Interval (2-Sided) 95%
    0 to 0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in EWB between treatment arms (EOT) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6699
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.42
    Confidence Interval (2-Sided) 95%
    -2.37 to 1.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in FWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0055
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -2.34
    Confidence Interval (2-Sided) 95%
    -3.98 to -0.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in FWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2793
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -1.04
    Confidence Interval (2-Sided) 95%
    -2.92 to 0.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in FWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2999
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -1.09
    Confidence Interval (2-Sided) 95%
    -3.17 to 0.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in FWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3270
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -1.27
    Confidence Interval (2-Sided) 95%
    -3.82 to 1.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in FWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9779
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.03
    Confidence Interval (2-Sided) 95%
    -2.39 to 2.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in FWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8344
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.40
    Confidence Interval (2-Sided) 95%
    -4.25 to 3.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in FWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5494
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 1.46
    Confidence Interval (2-Sided) 95%
    -3.50 to 6.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in FWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0136
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 13.00
    Confidence Interval (2-Sided) 95%
    3.15 to 22.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in FWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0247
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 13.78
    Confidence Interval (2-Sided) 95%
    2.26 to 25.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in FWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3527
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 5.00
    Confidence Interval (2-Sided) 95%
    -12.91 to 22.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in FWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0
    Confidence Interval (2-Sided) 95%
    0 to 0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in FWB between treatment arms (EOT) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1309
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -1.76
    Confidence Interval (2-Sided) 95%
    -4.05 to 0.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in CCS between treatment arms (C4 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0510
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -1.36
    Confidence Interval (2-Sided) 95%
    -2.72 to 0.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in CCS between treatment arms (C7 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3858
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.74
    Confidence Interval (2-Sided) 95%
    -2.44 to 0.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in CCS between treatment arms (C10 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3943
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.88
    Confidence Interval (2-Sided) 95%
    -2.90 to 1.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in CCS between treatment arms (C13 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3499
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -1.13
    Confidence Interval (2-Sided) 95%
    -3.53 to 1.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in CCS between treatment arms (C16 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9567
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.07
    Confidence Interval (2-Sided) 95%
    -2.64 to 2.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in CCS between treatment arms (C19 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2901
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -1.77
    Confidence Interval (2-Sided) 95%
    -5.12 to 1.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in CCS between treatment arms (C22 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5857
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -1.07
    Confidence Interval (2-Sided) 95%
    -5.05 to 2.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in CCS between treatment arms (C25 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9635
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.27
    Confidence Interval (2-Sided) 95%
    -12.56 to 12.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in CCS between treatment arms (C28 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6850
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -2.40
    Confidence Interval (2-Sided) 95%
    -15.36 to 10.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in CCS between treatment arms (C31 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4968
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -3.75
    Confidence Interval (2-Sided) 95%
    -19.23 to 11.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in CCS between treatment arms (C34 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0
    Confidence Interval (2-Sided) 95%
    0 to 0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in CCS between treatment arms (EOT) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5891
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.58
    Confidence Interval (2-Sided) 95%
    -2.71 to 1.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    Title Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score
    Description FACT&GOG-Ntx has a 13-item, treatment-specific subscale for patients with neurotoxicity. It is the sum of the PWB (7 items), FWB (7 items), SWB (7 items) and EWB (6 items) subscales plus a 13 item neurotoxicity subscale. Subscale score ranges from 0 to 28 for PWB, FWB, SWB, 0 to 24 for EWB and 0 to 52 for neurotoxicity subscale. Total possible score range is 0 to 160. Higher scores indicates better QoL, fewer disease symptoms, and/or fewer side effects of treatment and lower scores indicate worse QoL and a greater impact of disease symptoms and/or side effects.
    Time Frame Baseline (D1 of C1) then every 3 cycles thereafter and at the EOT or withdrawal visit (up to 115 weeks)

    Outcome Measure Data

    Analysis Population Description
    The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.
    Arm/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
    Arm/Group Description Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle. Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
    Measure Participants 96 95
    Baseline (Neurotoxicity) (n=90, 93)
    44.04
    (4.853)
    44.41
    (4.808)
    Change at C4 D1 (Neurotoxicity) (n=75, 80)
    -4.73
    (6.270)
    -4.10
    (5.514)
    Change at C7 D1 (Neurotoxicity) (n=60, 74)
    -6.20
    (7.504)
    -5.76
    (5.560)
    Change at C10 D1 (Neurotoxicity) (n=45, 61)
    -10.21
    (8.800)
    -7.45
    (7.231)
    Change at C13 D1 (Neurotoxicity) (n=34, 40)
    -13.96
    (9.494)
    -12.73
    (9.420)
    Change at C16 D1 (Neurotoxicity) (n=24, 31)
    -15.58
    (8.356)
    -14.55
    (10.977)
    Change at C19 D1 (Neurotoxicity) (n=13, 23)
    -12.4
    (8.58)
    -16.6
    (9.71)
    Change at C22 D1 (Neurotoxicity) (n=5, 20)
    -5.60
    (6.914)
    -13.87
    (8.122)
    Change at C25 D1 (Neurotoxicity) (n=1, 14)
    -13.0
    (NA)
    -16.9
    (9.09)
    Change at C28 D1 (Neurotoxicity) (n=1, 10)
    -13.0
    (NA)
    -14.0
    (8.03)
    Change at C31 D1 (Neurotoxicity) (n=1, 4)
    -12.0
    (NA)
    -13.8
    (4.11)
    Change at C34 D1 (Neurotoxicity) (n=1, 1)
    -12.0
    (NA)
    -9.0
    (NA)
    Change at C37 D1 (Neurotoxicity) (n=0, 1)
    NA
    (NA)
    -9.0
    (NA)
    Change at C40 D1 (Neurotoxicity) (n=0, 1)
    NA
    (NA)
    -10.0
    (NA)
    Change at C43 D1 (Neurotoxicity) (n=0, 1)
    NA
    (NA)
    -10.0
    (NA)
    Change at C46 D1 (Neurotoxicity) (n=0, 1)
    NA
    (NA)
    -8.0
    (NA)
    Change at C49 D1 (Neurotoxicity) (n=0, 1)
    NA
    (NA)
    -8.0
    (NA)
    Change at EOT (Neurotoxicity) (n=56, 43)
    -10.71
    (9.561)
    -9.97
    (8.632)
    Baseline (Item 13) (n=90, 93)
    3.8
    (0.55)
    3.9
    (0.42)
    Change at C4 D1 (Item 13) (n=75, 79)
    -0.2
    (0.52)
    -0.2
    (0.65)
    Change at C7 D1 (Item 13) (n=60, 74)
    -0.3
    (0.68)
    -0.2
    (0.56)
    Change at C10 D1 (Item 13) (n=45, 61)
    -0.4
    (0.87)
    -0.2
    (0.79)
    Change at C13 D1 (Item 13) (n=34, 40)
    -0.4
    (0.86)
    -0.2
    (0.68)
    Change at C16 D1 (Item 13) (n=24, 31)
    -0.6
    (1.03)
    -0.6
    (0.89)
    Change at C19 D1 (Item 13) (n=13, 23)
    -0.3
    (0.48)
    -0.7
    (1.19)
    Change at C22 D1 (Item 13) (n=5, 20)
    -0.4
    (0.55)
    -0.4
    (0.88)
    Change at C25 D1 (Item 13) (n=1, 14)
    0.0
    (NA)
    -0.6
    (0.94)
    Change at C28 D1 (Item 13) (n=1, 10)
    -1.0
    (NA)
    -0.6
    (1.07)
    Change at C31 D1 (Item 13) (n=1, 4)
    0.0
    (NA)
    -1.3
    (0.96)
    Change at C34 D1 (Item 13) (n=1, 1)
    -1.0
    (NA)
    -1.0
    (NA)
    Change at C37 D1 (Item 13) (n=0, 1)
    NA
    (NA)
    -1.0
    (NA)
    Change at C40 D1 (Item 13) (n=0, 1)
    NA
    (NA)
    0.0
    (NA)
    Change at C43 D1 (Item 13) (n=0, 1)
    NA
    (NA)
    0.0
    (NA)
    Change at C46 D1 (Item 13) (n=0, 1)
    NA
    (NA)
    0.0
    (NA)
    Change at C49 D1 (Item 13) (n=0, 1)
    NA
    (NA)
    0.0
    (NA)
    Change at EOT (Item 13) (n=56, 43)
    -0.4
    (0.85)
    -0.3
    (0.78)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in neurotoxicity between treatment arms (C4 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5081
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.63
    Confidence Interval (2-Sided) 95%
    -2.50 to 1.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in neurotoxicity between treatment arms (C7 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6977
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.44
    Confidence Interval (2-Sided) 95%
    -2.67 to 1.79
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in neurotoxicity between treatment arms (C10 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0797
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -2.76
    Confidence Interval (2-Sided) 95%
    -5.85 to 0.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in neurotoxicity between treatment arms (C13 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5808
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -1.22
    Confidence Interval (2-Sided) 95%
    -5.62 to 3.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in neurotoxicity between treatment arms (C16 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7046
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -1.03
    Confidence Interval (2-Sided) 95%
    -6.44 to 4.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in neurotoxicity between treatment arms (C19 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2052
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 4.18
    Confidence Interval (2-Sided) 95%
    -2.40 to 10.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in neurotoxicity between treatment arms (C22 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0483
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 8.27
    Confidence Interval (2-Sided) 95%
    0.07 to 16.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in neurotoxicity between treatment arms (C25 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6832
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 3.93
    Confidence Interval (2-Sided) 95%
    -16.41 to 24.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in neurotoxicity between treatment arms (C28 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9081
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 1.00
    Confidence Interval (2-Sided) 95%
    -18.05 to 20.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in neurotoxicity between treatment arms (C31 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7289
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 1.75
    Confidence Interval (2-Sided) 95%
    -12.88 to 16.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in neurotoxicity between treatment arms (C34 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0
    Confidence Interval (2-Sided) 95%
    0 to 0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in neurotoxicity between treatment arms (EOT) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6921
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.74
    Confidence Interval (2-Sided) 95%
    -4.43 to 2.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in item 13 between treatment arms (C4 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9788
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.00
    Confidence Interval (2-Sided) 95%
    -0.19 to 0.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in item 13 between treatment arms (C7 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2747
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.12
    Confidence Interval (2-Sided) 95%
    -0.33 to 0.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in item 13 between treatment arms (C10 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2776
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.18
    Confidence Interval (2-Sided) 95%
    -0.50 to 0.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in item 13 between treatment arms (C13 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1403
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.27
    Confidence Interval (2-Sided) 95%
    -0.62 to 0.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in item 13 between treatment arms (C16 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9151
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.03
    Confidence Interval (2-Sided) 95%
    -0.55 to 0.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in item 13 between treatment arms (C19 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3277
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.34
    Confidence Interval (2-Sided) 95%
    -0.36 to 1.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in item 13 between treatment arms (C22 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.00
    Confidence Interval (2-Sided) 95%
    -0.86 to 0.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in item 13 between treatment arms (C25 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5661
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.57
    Confidence Interval (2-Sided) 95%
    -1.53 to 2.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in item 13 between treatment arms (C28 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7309
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.40
    Confidence Interval (2-Sided) 95%
    -2.95 to 2.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in item 13 between treatment arms (C31 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3273
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 1.25
    Confidence Interval (2-Sided) 95%
    -2.16 to 4.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in item 13 between treatment arms (C34 of D1) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0
    Confidence Interval (2-Sided) 95%
    0 to 0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
    Comments Differences in item 13 between treatment arms (EOT) was analyzed from a two-sample t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7108
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.06
    Confidence Interval (2-Sided) 95%
    -0.39 to 0.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description Same event may appear as both AE and SAE. But distinct events are presented. Event may be serious in 1 subject and nonserious in another, or 1 subject may have both serious, nonserious event. At risk population=participants with metastatic colorectal cancer, with at least 1 dose of study medication; Sunitinib+mFOLFOX6=96, Bevacizumab+mFOLFOX6=93.
    Arm/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
    Arm/Group Description Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle. Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
    All Cause Mortality
    Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 36/96 (37.5%) 30/93 (32.3%)
    Blood and lymphatic system disorders
    Febrile neutropenia 5/96 (5.2%) 0/93 (0%)
    Neutropenia 1/96 (1%) 0/93 (0%)
    Pancytopenia 2/96 (2.1%) 0/93 (0%)
    Thrombocytopenia 1/96 (1%) 0/93 (0%)
    Cardiac disorders
    Cardiac failure congestive 0/96 (0%) 1/93 (1.1%)
    Coronary artery disease 0/96 (0%) 1/93 (1.1%)
    Left ventricular dysfunction 1/96 (1%) 0/93 (0%)
    Prinzmetal angina 1/96 (1%) 0/93 (0%)
    Eye disorders
    Ocular icterus 0/96 (0%) 1/93 (1.1%)
    Gastrointestinal disorders
    Abdominal pain 1/96 (1%) 0/93 (0%)
    Anal haemorrhage 0/96 (0%) 1/93 (1.1%)
    Constipation 0/96 (0%) 1/93 (1.1%)
    Diarrhoea 0/96 (0%) 2/93 (2.2%)
    Enterocutaneous fistula 1/96 (1%) 0/93 (0%)
    Gastric perforation 0/96 (0%) 1/93 (1.1%)
    Gastritis 1/96 (1%) 0/93 (0%)
    Intestinal obstruction 3/96 (3.1%) 0/93 (0%)
    Intestinal perforation 0/96 (0%) 1/93 (1.1%)
    Lower gastrointestinal haemorrhage 0/96 (0%) 1/93 (1.1%)
    Melaena 0/96 (0%) 1/93 (1.1%)
    Nausea 0/96 (0%) 1/93 (1.1%)
    Rectal ulcer 0/96 (0%) 1/93 (1.1%)
    Small intestinal obstruction 1/96 (1%) 2/93 (2.2%)
    Vomiting 2/96 (2.1%) 1/93 (1.1%)
    General disorders
    Adverse drug reaction 1/96 (1%) 0/93 (0%)
    Chest pain 0/96 (0%) 2/93 (2.2%)
    Device dislocation 0/96 (0%) 1/93 (1.1%)
    Disease progression 4/96 (4.2%) 3/93 (3.2%)
    Medical device complication 0/96 (0%) 1/93 (1.1%)
    Pain 1/96 (1%) 1/93 (1.1%)
    Pyrexia 1/96 (1%) 2/93 (2.2%)
    Hepatobiliary disorders
    Cholangitis 0/96 (0%) 1/93 (1.1%)
    Cholestasis 1/96 (1%) 0/93 (0%)
    Hepatitis 0/96 (0%) 1/93 (1.1%)
    Immune system disorders
    Anaphylactic reaction 1/96 (1%) 0/93 (0%)
    Drug hypersensitivity 1/96 (1%) 0/93 (0%)
    Infections and infestations
    Abdominal infection 1/96 (1%) 0/93 (0%)
    Abdominal wall infection 1/96 (1%) 0/93 (0%)
    Abscess 1/96 (1%) 0/93 (0%)
    Bacteraemia 2/96 (2.1%) 0/93 (0%)
    Bronchitis 0/96 (0%) 1/93 (1.1%)
    Clostridium difficile colitis 1/96 (1%) 0/93 (0%)
    Cystitis 1/96 (1%) 0/93 (0%)
    Haemophilus bacteraemia 0/96 (0%) 1/93 (1.1%)
    Herpes zoster 1/96 (1%) 0/93 (0%)
    Infection 1/96 (1%) 0/93 (0%)
    Lung infection 1/96 (1%) 0/93 (0%)
    Pneumonia 2/96 (2.1%) 2/93 (2.2%)
    Post procedural infection 1/96 (1%) 0/93 (0%)
    Septic shock 0/96 (0%) 1/93 (1.1%)
    Injury, poisoning and procedural complications
    Wound dehiscence 1/96 (1%) 0/93 (0%)
    Investigations
    Platelet count decreased 1/96 (1%) 0/93 (0%)
    Metabolism and nutrition disorders
    Dehydration 5/96 (5.2%) 2/93 (2.2%)
    Diabetic ketoacidosis 0/96 (0%) 1/93 (1.1%)
    Musculoskeletal and connective tissue disorders
    Costochondritis 0/96 (0%) 1/93 (1.1%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer 0/96 (0%) 1/93 (1.1%)
    Nervous system disorders
    Depressed level of consciousness 1/96 (1%) 0/93 (0%)
    Dizziness 0/96 (0%) 1/93 (1.1%)
    Syncope 0/96 (0%) 1/93 (1.1%)
    Renal and urinary disorders
    Calculus ureteric 1/96 (1%) 0/93 (0%)
    Renal failure acute 1/96 (1%) 0/93 (0%)
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 0/96 (0%) 1/93 (1.1%)
    Dyspnoea 2/96 (2.1%) 2/93 (2.2%)
    Epistaxis 1/96 (1%) 0/93 (0%)
    Lung infiltration 1/96 (1%) 0/93 (0%)
    Pleuritic pain 1/96 (1%) 0/93 (0%)
    Pulmonary embolism 0/96 (0%) 2/93 (2.2%)
    Pulmonary hypertension 1/96 (1%) 0/93 (0%)
    Respiratory distress 1/96 (1%) 0/93 (0%)
    Respiratory failure 0/96 (0%) 1/93 (1.1%)
    Skin and subcutaneous tissue disorders
    Angioedema 1/96 (1%) 0/93 (0%)
    Surgical and medical procedures
    Hepatectomy 0/96 (0%) 1/93 (1.1%)
    Vascular disorders
    Deep vein thrombosis 0/96 (0%) 3/93 (3.2%)
    Haemorrhage 1/96 (1%) 0/93 (0%)
    Jugular vein thrombosis 0/96 (0%) 2/93 (2.2%)
    Subclavian vein thrombosis 0/96 (0%) 1/93 (1.1%)
    Thrombosis 0/96 (0%) 1/93 (1.1%)
    Other (Not Including Serious) Adverse Events
    Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 96/96 (100%) 93/93 (100%)
    Blood and lymphatic system disorders
    Anaemia 27/96 (28.1%) 26/93 (28%)
    Leukopenia 21/96 (21.9%) 11/93 (11.8%)
    Neutropenia 67/96 (69.8%) 33/93 (35.5%)
    Thrombocytopenia 50/96 (52.1%) 19/93 (20.4%)
    Eye disorders
    Lacrimation increased 5/96 (5.2%) 5/93 (5.4%)
    Vision blurred 6/96 (6.3%) 3/93 (3.2%)
    Gastrointestinal disorders
    Abdominal distension 6/96 (6.3%) 5/93 (5.4%)
    Abdominal pain 20/96 (20.8%) 21/93 (22.6%)
    Abdominal pain lower 1/96 (1%) 5/93 (5.4%)
    Abdominal pain upper 6/96 (6.3%) 7/93 (7.5%)
    Cheilitis 4/96 (4.2%) 5/93 (5.4%)
    Constipation 22/96 (22.9%) 30/93 (32.3%)
    Diarrhoea 66/96 (68.8%) 49/93 (52.7%)
    Dry mouth 11/96 (11.5%) 5/93 (5.4%)
    Dyspepsia 17/96 (17.7%) 7/93 (7.5%)
    Dysphagia 4/96 (4.2%) 7/93 (7.5%)
    Flatulence 5/96 (5.2%) 7/93 (7.5%)
    Gastrooesophageal reflux disease 11/96 (11.5%) 7/93 (7.5%)
    Haemorrhoids 0/96 (0%) 5/93 (5.4%)
    Nausea 62/96 (64.6%) 57/93 (61.3%)
    Oral pain 6/96 (6.3%) 5/93 (5.4%)
    Proctalgia 5/96 (5.2%) 2/93 (2.2%)
    Rectal haemorrhage 3/96 (3.1%) 5/93 (5.4%)
    Stomatitis 31/96 (32.3%) 26/93 (28%)
    Vomiting 33/96 (34.4%) 33/93 (35.5%)
    General disorders
    Asthenia 8/96 (8.3%) 11/93 (11.8%)
    Chest pain 2/96 (2.1%) 10/93 (10.8%)
    Chills 2/96 (2.1%) 6/93 (6.5%)
    Fatigue 65/96 (67.7%) 62/93 (66.7%)
    Mucosal inflammation 12/96 (12.5%) 21/93 (22.6%)
    Oedema peripheral 11/96 (11.5%) 5/93 (5.4%)
    Pain 7/96 (7.3%) 9/93 (9.7%)
    Pyrexia 21/96 (21.9%) 22/93 (23.7%)
    Immune system disorders
    Hypersensitivity 2/96 (2.1%) 5/93 (5.4%)
    Infections and infestations
    Nasopharyngitis 4/96 (4.2%) 9/93 (9.7%)
    Rhinitis 0/96 (0%) 7/93 (7.5%)
    Upper respiratory tract infection 4/96 (4.2%) 6/93 (6.5%)
    Urinary tract infection 10/96 (10.4%) 3/93 (3.2%)
    Injury, poisoning and procedural complications
    Contusion 5/96 (5.2%) 1/93 (1.1%)
    Investigations
    Blood alkaline phosphatase increased 5/96 (5.2%) 5/93 (5.4%)
    Blood potassium decreased 5/96 (5.2%) 1/93 (1.1%)
    Haemoglobin decreased 6/96 (6.3%) 2/93 (2.2%)
    Neutrophil count decreased 19/96 (19.8%) 8/93 (8.6%)
    Platelet count decreased 17/96 (17.7%) 0/93 (0%)
    Weight decreased 19/96 (19.8%) 16/93 (17.2%)
    White blood cell count decreased 13/96 (13.5%) 5/93 (5.4%)
    Metabolism and nutrition disorders
    Decreased appetite 32/96 (33.3%) 36/93 (38.7%)
    Dehydration 11/96 (11.5%) 6/93 (6.5%)
    Hyperglycaemia 3/96 (3.1%) 6/93 (6.5%)
    Hypocalcaemia 5/96 (5.2%) 2/93 (2.2%)
    Hypokalaemia 18/96 (18.8%) 10/93 (10.8%)
    Hypomagnesaemia 5/96 (5.2%) 2/93 (2.2%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 5/96 (5.2%) 7/93 (7.5%)
    Back pain 13/96 (13.5%) 8/93 (8.6%)
    Bone pain 4/96 (4.2%) 7/93 (7.5%)
    Musculoskeletal pain 6/96 (6.3%) 6/93 (6.5%)
    Myalgia 4/96 (4.2%) 8/93 (8.6%)
    Pain in extremity 8/96 (8.3%) 10/93 (10.8%)
    Nervous system disorders
    Dizziness 14/96 (14.6%) 16/93 (17.2%)
    Dysgeusia 31/96 (32.3%) 21/93 (22.6%)
    Headache 14/96 (14.6%) 22/93 (23.7%)
    Hyperaesthesia 7/96 (7.3%) 8/93 (8.6%)
    Hypoaesthesia 5/96 (5.2%) 5/93 (5.4%)
    Neuropathy peripheral 39/96 (40.6%) 37/93 (39.8%)
    Paraesthesia 6/96 (6.3%) 14/93 (15.1%)
    Peripheral sensory neuropathy 29/96 (30.2%) 33/93 (35.5%)
    Polyneuropathy 0/96 (0%) 5/93 (5.4%)
    Psychiatric disorders
    Anxiety 5/96 (5.2%) 13/93 (14%)
    Depression 6/96 (6.3%) 11/93 (11.8%)
    Insomnia 16/96 (16.7%) 20/93 (21.5%)
    Renal and urinary disorders
    Proteinuria 3/96 (3.1%) 5/93 (5.4%)
    Respiratory, thoracic and mediastinal disorders
    Cough 15/96 (15.6%) 16/93 (17.2%)
    Dysphonia 2/96 (2.1%) 11/93 (11.8%)
    Dyspnoea 16/96 (16.7%) 14/93 (15.1%)
    Dyspnoea exertional 6/96 (6.3%) 4/93 (4.3%)
    Epistaxis 22/96 (22.9%) 30/93 (32.3%)
    Hiccups 10/96 (10.4%) 7/93 (7.5%)
    Oropharyngeal pain 7/96 (7.3%) 8/93 (8.6%)
    Rhinorrhoea 3/96 (3.1%) 5/93 (5.4%)
    Skin and subcutaneous tissue disorders
    Alopecia 17/96 (17.7%) 24/93 (25.8%)
    Dry skin 9/96 (9.4%) 5/93 (5.4%)
    Hyperhidrosis 3/96 (3.1%) 5/93 (5.4%)
    Palmar-plantar erythrodysaesthesia syndrome 26/96 (27.1%) 15/93 (16.1%)
    Pruritus 7/96 (7.3%) 9/93 (9.7%)
    Rash 20/96 (20.8%) 16/93 (17.2%)
    Skin discolouration 9/96 (9.4%) 5/93 (5.4%)
    Skin hyperpigmentation 2/96 (2.1%) 8/93 (8.6%)
    Yellow skin 9/96 (9.4%) 0/93 (0%)
    Vascular disorders
    Hypertension 19/96 (19.8%) 21/93 (22.6%)
    Hypotension 2/96 (2.1%) 6/93 (6.5%)

    Limitations/Caveats

    Due to early study termination, not all data was analyzable.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

    Results Point of Contact

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer, Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00609622
    Other Study ID Numbers:
    • A6181104
    First Posted:
    Feb 7, 2008
    Last Update Posted:
    Oct 11, 2012
    Last Verified:
    Sep 1, 2012