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IXTEND: Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer

Sponsor
R-Pharm (Industry)
Overall Status
Terminated
CT.gov ID
NCT00546364
Collaborator
(none)
62
Enrollment
60
Locations
3
Arms
24.9
Duration (Months)
1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effect of ixabepilone plus capecitabine or docetaxel plus capecitabine on shrinking or slowing the growth of metastatic breast cancer in women. The safety of this combination therapy will also be evaluated.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
  • Drug: Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
  • Drug: Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
IXTEND: A Randomized Phase 2 Study to Evaluate the Combination of Ixabepilone Plus Capecitabine or Capecitabine Plus Docetaxel in the Treatment of Metastatic Breast Cancer
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2

Drug: Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
Other Names:
  • IXEMPRA®
  • BMS-247550

    		•
    Experimental: Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2

    Drug: Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
    Ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
    Active Comparator: Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2

    Drug: Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
    Docetaxel 75 mg/m^2 administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) [Baseline to 6 weeks (end of Cycle 2)]

      RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.

    2. Percentage of Participants With Best Response to Treatment of Complete or Partial [Baseline to 6 weeks (end of Cycle 2)]

      The tumor response rate is defined as the number of participants with a best tumor response of CR or PR (as assessed by the investigator according to RECIST criteria), divided by the number of participants randomized in that arm.

    Secondary Outcome Measures

    1. Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial [Baseline to 6 weeks (end of Cycle 2)]

      The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not over express human epidermal growth factor receptor 2 (HER2).

    2. Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort [Baseline to 6 weeks (end of Cycle 2)]

      The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. NTN participants are who are not TN participants (TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not overexpress HER2) and who received ixabepilone plus capecitabine or docetaxel plus capecitabine.

    3. Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy [Baseline to end of Cycle 1 (21 days), continuously]

      An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related or of unknown relationship to study treatment. Grade 3=Severe, Grade 4=Life-threatening.

    4. Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade [Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle]

      CTC Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2=Moderate; minimal, local or noninvasive intervention indicated. Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4=Life-threatening consequences; urgent intervention indicated.

    5. Number of Participants With Abnormalities in Serum Chemistry Laboratory Results [Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle]

      ULN=Upper limit of normal among all laboratory ranges. Alanine aminotransferase (ALT) Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Aspartate aminotransferase (AST) Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. Creatine Grade 1: >ULN to 1.5*ULN; Grade 2: 1.5 to 3.0*ULN; Grade 3: >3.0 to 6.0*ULN; Grade 4: >6.0*ULN.

    6. Time to Progression [Baseline to date progressive disease reported]

      Time to progression is defined as the time from date of randomization until the date that PD is first reported. Participants who die without a reported prior progression are considered to have progressed on the day of their death. Those who did not progress or die are censored at the day of their last tumor assessment.

    7. Duration of Response [Baseline (date of randomization) to date CR or PR criteria first met]

      Duration of overall response is computed for participants whose best response is either PR or CR and is measured from the time measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of documented PD or death. Participants who did not relapse or die are censored on the date of their last tumor assessment.

    8. Median Number of Treatment Cycles [Day 1 to end of Cycle 18, maximum (54 weeks)]

      The first dosing date is defined as the date of the first dose of chemotherapy or capecitabine, whichever was administered first. Cycles are defined as the time from Day 1 of the cycle until the day before the next cycle. The last cycle per participant is the 21-day period following Day 1 of that cycle.

    Eligibility Criteria

    Criteria

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

    • Participants with metastatic breast cancer

    • Measurable disease

    • Up to 1 chemotherapy regimen is acceptable. Participants who have received paclitaxel in the neoadjuvant or adjuvant setting acceptable, only if the last dose of paclitaxel was received 12 months or less before the treatment. There is no timeframe for prior paclitaxel in the metastatic setting.

    • Human epidermal growth factor receptor 2-positive participants allowed if they have progressed after receiving treatment with trastuzumab or lapatinib

    • Eastern Cooperative Oncology Group Performance status of 0-1

    • Age younger than 18 years

    • Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of investigational products

    Exclusion Criteria:

    • More than 1 chemotherapy regimen for the treatment of metastatic breast cancer

    • Prior treatment with any epothilone, capecitabine, or docetaxel

    • Prior radiation must not have included 30% or more of major bone marrow-containing areas (pelvis, lumbar spine). If prior radiation was less than 30%, a minimum interval of 2 weeks must be allowed between the last radiation treatment and administration of study medication. There must be at least 1 week between focal/palliative radiation and administration of study medication.

    • Any current or previous history of brain and/or leptomeningeal metastases

    • Neuropathy greater than Grade 2

    • Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix

    • Uncontrolled diabetes mellitus

    • Chronic hepatitis

    • HIV-positive status

    • Administration of trastuzumab, lapatinib, bevacizumab, or other systemic treatment for cancer must be discontinued 28 days prior to study medication. Hormonal anticancer agents must be discontinued at least 14 days prior to study medication. Hormonal replacement therapy is acceptable

    • Biphosphonates for palliation of bone metastases allowed if initiated at least 7 days before study entry

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dch Cancer Treatment Center Tuscaloosa Alabama United States 35401
    2 Scripps Cancer Center La Jolla California United States 92037
    3 Cancer Center of Central Connecticut Southington Connecticut United States 06489
    4 Local Institution Newark Delaware United States 19718
    5 Georgetown University Medical Center Washington District of Columbia United States 20007
    6 Local Institution Jacksonville Florida United States 32209
    7 Local Institution Miami Florida United States 33176
    8 Medical Oncology Associates of Augusta, PC Augusta Georgia United States 30901
    9 Local Institution Honolulu Hawaii United States 96813
    10 Northwestern University Feinberg School of Medicine Chicago Illinois United States 60611
    11 John W Kugler, MD Peoria Illinois United States 61615
    12 Midwestern Regional Medical Center Zion Illinois United States 60099
    13 Center for Cancer Care at Goshen Health System Goshen Indiana United States 46526
    14 Monroe Medical Associates Munster Indiana United States 46321
    15 Cancer Center of Kansas Wichita Kansas United States 67214
    16 University of Kentucky Lexington Kentucky United States 40536
    17 University Medical Center, Inc Louisville Kentucky United States 40202
    18 Hematology/Oncology Clinic Baton Rouge Louisiana United States 70809
    19 Mary Bird Perkins Cancer Center Baton Rouge Louisiana United States 70809
    20 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
    21 Center for Cancer & Blood Disorders, PC Bethesda Maryland United States 20817
    22 Jackson Oncology Associates, Pllc Jackson Mississippi United States 39202
    23 The Center for Cancer and Hematologic Disease Cherry Hill New Jersey United States 08003
    24 The Cancer Center at Hackensack University Medical Center Hackensack New Jersey United States 07601
    25 Howell Office Plaza Howell New Jersey United States 07731
    26 Local Institution Newark New Jersey United States 07112
    27 Cooper Hospital, Division of Hematology/Oncology Voorhees New Jersey United States 08043
    28 UNM Cancer Center Albuquerque New Mexico United States 87106
    29 New Mexico Cancer Care Associates (NMCCA) Santa Fe New Mexico United States 87505
    30 Arena Oncology Associates, PC Lake Success New York United States 11042
    31 Hematology Oncology Associates of Rockland Nyack New York United States 10960
    32 Gaston Hematology and Oncology Gastonia North Carolina United States 28054
    33 Marion L Shepard Cancer Center Washington North Carolina United States 27889
    34 Akron General Medical Center Akron Ohio United States 44302
    35 Summa Health System Akron Ohio United States 44304
    36 Local Institution Canton Ohio United States 44710
    37 Mid Ohio Oncology/Hematology, Inc, dba The Mark H Zangmeister Center Columbus Ohio United States 43219
    38 Doylestown Hospital Doylestown Pennsylvania United States 18901
    39 Hematology & Oncology Associates of Nepa Dunmore Pennsylvania United States 18512
    40 Regional Hematology Oncology, PC Langhorne Pennsylvania United States 19047
    41 St Mary Medical Center Langhorne Pennsylvania United States 19047
    42 Local Institution Philadelphia Pennsylvania United States 19140
    43 Albert Einstein Cancer Center Philadelphia Pennsylvania United States 19141
    44 Local Institution Woonsocket Rhode Island United States 02895
    45 Charleston Cancer Center Charleston South Carolina United States 29406
    46 Lowcountry Hematology & Oncology, PA Mt Pleasant South Carolina United States 29464
    47 Santee Hematology/Oncology Sumter South Carolina United States 29150
    48 Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota United States 57104
    49 Kingsport Hematology Oncology Kingsport Tennessee United States 37660
    50 The University of Tennessee Medical Center Knoxville Tennessee United States 37920
    51 Austin Cancer Centers Austin Texas United States 78759
    52 Cancer Specialists of South Texas Corpus Christi Texas United States 78412
    53 Coastal Bend Cancer Center Corpus Christi Texas United States 78463
    54 Edward L Middleman, MD Duncanville Texas United States 75137
    55 Section Chief Medical Oncology Houston Texas United States 77030
    56 Jose A Figueroa, MD Lubbock Texas United States 79410
    57 Southlake Oncology Southlake Texas United States 76092
    58 Peninsula Cancer Institute Newport News Virginia United States 23601
    59 Providence Cancer Center Spokane Washington United States 99204
    60 Leah L Dietrich, MD La Crosse Wisconsin United States 54601

    Sponsors and Collaborators

    • R-Pharm

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    R-Pharm
    ClinicalTrials.gov Identifier:
    NCT00546364
    Other Study ID Numbers:
    • CA163-131
    First Posted:
    Oct 18, 2007
    Last Update Posted:
    Mar 10, 2016
    Last Verified:
    Feb 1, 2016
    Additional relevant MeSH terms:
    Breast Neoplasms
    Docetaxel
    Capecitabine
    Epothilones

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Of 62 participants enrolled, 62 were randomized and received treatment. Investigators had to terminate the study because an adequate number of participants could not be enrolled.
    Arm/Group Title Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
    Arm/Group Description Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
    Period Title: Overall Study
    STARTED 20 22 20
    Never Treated 0 0 0
    COMPLETED 3 4 3
    NOT COMPLETED 17 18 17

    Baseline Characteristics

    Arm/Group Title Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 Total
    Arm/Group Description Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Total of all reporting groups
    Overall Participants 20 22 20 62
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    55.5
    59
    55.5
    57.5
    Sex: Female, Male (Count of Participants)
    Female
    20
    100%
    22
    100%
    20
    100%
    62
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    5
    25%
    4
    18.2%
    4
    20%
    13
    21%
    White
    15
    75%
    18
    81.8%
    16
    80%
    49
    79%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
    Description RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.
    Time Frame Baseline to 6 weeks (end of Cycle 2)

    Outcome Measure Data

    Analysis Population Description
    All participants with measurable disease who have a correct cancer diagnosis and have received any treatment.
    Arm/Group Title Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
    Arm/Group Description Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
    Measure Participants 20 22 20
    Complete response (CR)
    1
    5%
    1
    4.5%
    0
    0%
    Partial response (PR)
    6
    30%
    8
    36.4%
    6
    30%
    Stable disease (SD)
    6
    30%
    3
    13.6%
    3
    15%
    Progressive disease (PD)
    4
    20%
    9
    40.9%
    9
    45%
    Discontinued before first tumor assessment
    3
    15%
    0
    0%
    1
    5%
    No tumor assessment due to other reasons
    0
    0%
    0
    0%
    1
    5%
    Unable to determine
    0
    0%
    1
    4.5%
    0
    0%
    2. Secondary Outcome
    Title Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial
    Description The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not over express human epidermal growth factor receptor 2 (HER2).
    Time Frame Baseline to 6 weeks (end of Cycle 2)

    Outcome Measure Data

    Analysis Population Description
    All TN participants who received ixabepilone plus capecitabine or docetaxel plus capecitabine.
    Arm/Group Title Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
    Arm/Group Description Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
    Measure Participants 8 9 8
    Number [Percentage of TN Participants]
    38
    190%
    22
    100%
    13
    65%
    3. Secondary Outcome
    Title Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort
    Description The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. NTN participants are who are not TN participants (TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not overexpress HER2) and who received ixabepilone plus capecitabine or docetaxel plus capecitabine.
    Time Frame Baseline to 6 weeks (end of Cycle 2)

    Outcome Measure Data

    Analysis Population Description
    All NTN participants who received ixabepilone plus capecitabine or docetaxel plus capecitabine.
    Arm/Group Title Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
    Arm/Group Description Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
    Measure Participants 12 13 12
    Number [Percentage of NTN Participants]
    33
    165%
    54
    245.5%
    42
    210%
    4. Secondary Outcome
    Title Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
    Description An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related or of unknown relationship to study treatment. Grade 3=Severe, Grade 4=Life-threatening.
    Time Frame Baseline to end of Cycle 1 (21 days), continuously

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.
    Arm/Group Title Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
    Arm/Group Description Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
    Measure Participants 20 22 20
    Deaths
    2
    10%
    1
    4.5%
    2
    10%
    AEs
    20
    100%
    22
    100%
    20
    100%
    Drug-related AEs
    20
    100%
    22
    100%
    19
    95%
    Drug-related AEs (Grade 3)
    8
    40%
    9
    40.9%
    8
    40%
    Drug-related AEs (Grade 4)
    6
    30%
    3
    13.6%
    6
    30%
    SAEs
    7
    35%
    5
    22.7%
    5
    25%
    Drug-related SAEs
    3
    15%
    3
    13.6%
    3
    15%
    Drug-related SAEs (Grade 3)
    2
    10%
    2
    9.1%
    2
    10%
    Drug-related SAEs (Grade 4)
    1
    5%
    1
    4.5%
    1
    5%
    AEDs
    4
    20%
    9
    40.9%
    4
    20%
    Drug-related AEDs
    2
    10%
    7
    31.8%
    3
    15%
    Drug-related AEDs (Grade 3)
    1
    5%
    3
    13.6%
    2
    10%
    Drug-related AEDs (Grade 4)
    1
    5%
    1
    4.5%
    0
    0%
    Drug-related peripheral neuropathy
    10
    50%
    15
    68.2%
    5
    25%
    Drug-related peripheral neuropathy (Grade 3)
    4
    20%
    2
    9.1%
    0
    0%
    Drug-related peripheral neuropathy (Grade 4)
    0
    0%
    0
    0%
    0
    0%
    5. Secondary Outcome
    Title Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade
    Description CTC Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2=Moderate; minimal, local or noninvasive intervention indicated. Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4=Life-threatening consequences; urgent intervention indicated.
    Time Frame Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.
    Arm/Group Title Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
    Arm/Group Description Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
    Measure Participants 20 22 20
    Neutropenia (Grades 1-4)
    18
    90%
    15
    68.2%
    17
    85%
    Neutropenia (Grade 3 or 4)
    12
    60%
    10
    45.5%
    15
    75%
    Leukopenia (Grades 1-4)
    20
    100%
    19
    86.4%
    17
    85%
    Leukopenia (Grade 3 or 4)
    9
    45%
    9
    40.9%
    12
    60%
    Thrombocytopenia (Grades 1-4)
    9
    45%
    11
    50%
    7
    35%
    Thrombocytopenia (Grade 3 or 4)
    0
    0%
    1
    4.5%
    0
    0%
    Anemia (Grades 1-4)
    18
    90%
    21
    95.5%
    17
    85%
    Anemia (Grade 3 or 4)
    0
    0%
    1
    4.5%
    0
    0%
    6. Secondary Outcome
    Title Number of Participants With Abnormalities in Serum Chemistry Laboratory Results
    Description ULN=Upper limit of normal among all laboratory ranges. Alanine aminotransferase (ALT) Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Aspartate aminotransferase (AST) Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. Creatine Grade 1: >ULN to 1.5*ULN; Grade 2: 1.5 to 3.0*ULN; Grade 3: >3.0 to 6.0*ULN; Grade 4: >6.0*ULN.
    Time Frame Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.
    Arm/Group Title Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
    Arm/Group Description Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
    Measure Participants 20 22 20
    ALT, high (Grades 1-4)
    4
    20%
    3
    13.6%
    5
    25%
    ALT, high (Grade 3 or 4)
    0
    0%
    0
    0%
    0
    0%
    AST, high (Grades 1-4)
    7
    35%
    5
    22.7%
    5
    25%
    AST, high (Grade 3 or 4)
    0
    0%
    0
    0%
    0
    0%
    Total bilirubin, high (Grades 1-4)
    0
    0%
    1
    4.5%
    0
    0%
    Total bilirubin, high (Grade 3 or 4)
    0
    0%
    0
    0%
    0
    0%
    Creatinine, high (Grades 1-4)
    1
    5%
    1
    4.5%
    2
    10%
    Creatinine, high (Grade 3 or 4)
    0
    0%
    0
    0%
    0
    0%
    7. Secondary Outcome
    Title Time to Progression
    Description Time to progression is defined as the time from date of randomization until the date that PD is first reported. Participants who die without a reported prior progression are considered to have progressed on the day of their death. Those who did not progress or die are censored at the day of their last tumor assessment.
    Time Frame Baseline to date progressive disease reported

    Outcome Measure Data

    Analysis Population Description
    This study was terminated due to inadequate enrollment. Consequently, time to progression was not analyzed.
    Arm/Group Title Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
    Arm/Group Description Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
    Measure Participants 0 0 0
    8. Secondary Outcome
    Title Duration of Response
    Description Duration of overall response is computed for participants whose best response is either PR or CR and is measured from the time measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of documented PD or death. Participants who did not relapse or die are censored on the date of their last tumor assessment.
    Time Frame Baseline (date of randomization) to date CR or PR criteria first met

    Outcome Measure Data

    Analysis Population Description
    This study was terminated due to inadequate enrollment. Consequently, duration of response was not analyzed.
    Arm/Group Title Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
    Arm/Group Description Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
    Measure Participants 0 0 0
    9. Primary Outcome
    Title Percentage of Participants With Best Response to Treatment of Complete or Partial
    Description The tumor response rate is defined as the number of participants with a best tumor response of CR or PR (as assessed by the investigator according to RECIST criteria), divided by the number of participants randomized in that arm.
    Time Frame Baseline to 6 weeks (end of Cycle 2)

    Outcome Measure Data

    Analysis Population Description
    All participants with measurable disease who have a correct cancer diagnosis and have received any treatment.
    Arm/Group Title Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
    Arm/Group Description Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
    Measure Participants 20 22 20
    Number [Percentage of patients]
    35
    41
    30
    10. Secondary Outcome
    Title Median Number of Treatment Cycles
    Description The first dosing date is defined as the date of the first dose of chemotherapy or capecitabine, whichever was administered first. Cycles are defined as the time from Day 1 of the cycle until the day before the next cycle. The last cycle per participant is the 21-day period following Day 1 of that cycle.
    Time Frame Day 1 to end of Cycle 18, maximum (54 weeks)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.
    Arm/Group Title Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
    Arm/Group Description Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis. Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
    Measure Participants 20 22 20
    Median (Full Range) [Treatment cycles]
    3.0
    4.5
    6.0

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Docetaxel Ixabepilone 32 Ixabepilone 40
    Arm/Group Description
    All Cause Mortality
    Docetaxel Ixabepilone 32 Ixabepilone 40
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Docetaxel Ixabepilone 32 Ixabepilone 40
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/20 (25%) 5/22 (22.7%) 7/20 (35%)
    Blood and lymphatic system disorders
    NEUTROPENIA 1/20 (5%) 1/22 (4.5%) 0/20 (0%)
    FEBRILE NEUTROPENIA 2/20 (10%) 0/22 (0%) 0/20 (0%)
    Gastrointestinal disorders
    NAUSEA 0/20 (0%) 0/22 (0%) 1/20 (5%)
    DIARRHOEA 0/20 (0%) 2/22 (9.1%) 1/20 (5%)
    COLONIC OBSTRUCTION 0/20 (0%) 1/22 (4.5%) 0/20 (0%)
    General disorders
    ASTHENIA 0/20 (0%) 1/22 (4.5%) 0/20 (0%)
    OEDEMA PERIPHERAL 0/20 (0%) 1/22 (4.5%) 0/20 (0%)
    CATHETER THROMBOSIS 0/20 (0%) 0/22 (0%) 1/20 (5%)
    Infections and infestations
    URINARY TRACT INFECTION 0/20 (0%) 1/22 (4.5%) 0/20 (0%)
    Injury, poisoning and procedural complications
    INCISION SITE PAIN 0/20 (0%) 1/22 (4.5%) 0/20 (0%)
    Investigations
    BLOOD CREATININE INCREASED 0/20 (0%) 0/22 (0%) 1/20 (5%)
    NEUTROPHIL COUNT DECREASED 0/20 (0%) 0/22 (0%) 1/20 (5%)
    Metabolism and nutrition disorders
    DEHYDRATION 1/20 (5%) 1/22 (4.5%) 2/20 (10%)
    HYPOKALAEMIA 0/20 (0%) 1/22 (4.5%) 1/20 (5%)
    HYPONATRAEMIA 0/20 (0%) 0/22 (0%) 1/20 (5%)
    HYPOALBUMINAEMIA 0/20 (0%) 1/22 (4.5%) 0/20 (0%)
    ELECTROLYTE IMBALANCE 0/20 (0%) 1/22 (4.5%) 0/20 (0%)
    Musculoskeletal and connective tissue disorders
    BONE PAIN 0/20 (0%) 0/22 (0%) 1/20 (5%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    METASTASES TO CENTRAL NERVOUS SYSTEM 1/20 (5%) 0/22 (0%) 0/20 (0%)
    Nervous system disorders
    HEADACHE 0/20 (0%) 0/22 (0%) 1/20 (5%)
    DIZZINESS 0/20 (0%) 1/22 (4.5%) 0/20 (0%)
    SOMNOLENCE 0/20 (0%) 1/22 (4.5%) 0/20 (0%)
    DEPRESSED LEVEL OF CONSCIOUSNESS 0/20 (0%) 1/22 (4.5%) 0/20 (0%)
    Respiratory, thoracic and mediastinal disorders
    COUGH 0/20 (0%) 1/22 (4.5%) 0/20 (0%)
    DYSPNOEA 0/20 (0%) 1/22 (4.5%) 1/20 (5%)
    PNEUMOTHORAX 1/20 (5%) 0/22 (0%) 0/20 (0%)
    PULMONARY EMBOLISM 1/20 (5%) 0/22 (0%) 0/20 (0%)
    Vascular disorders
    EMBOLISM 0/20 (0%) 0/22 (0%) 1/20 (5%)
    HYPOTENSION 1/20 (5%) 0/22 (0%) 0/20 (0%)
    Other (Not Including Serious) Adverse Events
    Docetaxel Ixabepilone 32 Ixabepilone 40
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 20/20 (100%) 22/22 (100%) 20/20 (100%)
    Blood and lymphatic system disorders
    ANAEMIA 4/20 (20%) 6/22 (27.3%) 2/20 (10%)
    LEUKOPENIA 6/20 (30%) 2/22 (9.1%) 3/20 (15%)
    LYMPHOPENIA 3/20 (15%) 0/22 (0%) 0/20 (0%)
    NEUTROPENIA 11/20 (55%) 5/22 (22.7%) 5/20 (25%)
    MONOCYTOPENIA 1/20 (5%) 0/22 (0%) 0/20 (0%)
    THROMBOCYTOPENIA 2/20 (10%) 0/22 (0%) 0/20 (0%)
    Cardiac disorders
    TACHYCARDIA 1/20 (5%) 0/22 (0%) 0/20 (0%)
    PALPITATIONS 1/20 (5%) 0/22 (0%) 0/20 (0%)
    SINUS TACHYCARDIA 0/20 (0%) 0/22 (0%) 2/20 (10%)
    Ear and labyrinth disorders
    EAR PAIN 0/20 (0%) 0/22 (0%) 1/20 (5%)
    Eye disorders
    DRY EYE 0/20 (0%) 0/22 (0%) 1/20 (5%)
    PHOTOPHOBIA 1/20 (5%) 0/22 (0%) 0/20 (0%)
    VISION BLURRED 0/20 (0%) 2/22 (9.1%) 0/20 (0%)
    VISUAL IMPAIRMENT 1/20 (5%) 0/22 (0%) 0/20 (0%)
    LACRIMATION INCREASED 3/20 (15%) 1/22 (4.5%) 1/20 (5%)
    OCULAR SURFACE DISEASE 0/20 (0%) 0/22 (0%) 1/20 (5%)
    Gastrointestinal disorders
    NAUSEA 10/20 (50%) 17/22 (77.3%) 8/20 (40%)
    VOMITING 4/20 (20%) 8/22 (36.4%) 6/20 (30%)
    DIARRHOEA 8/20 (40%) 12/22 (54.5%) 9/20 (45%)
    DYSPEPSIA 2/20 (10%) 5/22 (22.7%) 1/20 (5%)
    DYSPHAGIA 2/20 (10%) 2/22 (9.1%) 0/20 (0%)
    GASTRITIS 1/20 (5%) 0/22 (0%) 0/20 (0%)
    FLATULENCE 1/20 (5%) 0/22 (0%) 1/20 (5%)
    STOMATITIS 4/20 (20%) 4/22 (18.2%) 5/20 (25%)
    CONSTIPATION 5/20 (25%) 7/22 (31.8%) 12/20 (60%)
    HAEMORRHOIDS 0/20 (0%) 0/22 (0%) 1/20 (5%)
    LIP SWELLING 0/20 (0%) 0/22 (0%) 1/20 (5%)
    ABDOMINAL PAIN 1/20 (5%) 3/22 (13.6%) 1/20 (5%)
    FAECAL INCONTINENCE 1/20 (5%) 0/22 (0%) 0/20 (0%)
    NEUTROPENIC COLITIS 0/20 (0%) 0/22 (0%) 1/20 (5%)
    ABDOMINAL PAIN UPPER 0/20 (0%) 2/22 (9.1%) 0/20 (0%)
    GASTROOESOPHAGEAL REFLUX DISEASE 1/20 (5%) 0/22 (0%) 0/20 (0%)
    General disorders
    PAIN 3/20 (15%) 2/22 (9.1%) 1/20 (5%)
    CHILLS 1/20 (5%) 2/22 (9.1%) 0/20 (0%)
    OEDEMA 1/20 (5%) 0/22 (0%) 1/20 (5%)
    FATIGUE 12/20 (60%) 17/22 (77.3%) 15/20 (75%)
    PYREXIA 5/20 (25%) 1/22 (4.5%) 3/20 (15%)
    XEROSIS 1/20 (5%) 0/22 (0%) 0/20 (0%)
    ASTHENIA 1/20 (5%) 0/22 (0%) 0/20 (0%)
    FIBROSIS 0/20 (0%) 0/22 (0%) 1/20 (5%)
    CHEST PAIN 1/20 (5%) 1/22 (4.5%) 1/20 (5%)
    OEDEMA PERIPHERAL 2/20 (10%) 5/22 (22.7%) 4/20 (20%)
    CATHETER SITE PAIN 1/20 (5%) 0/22 (0%) 0/20 (0%)
    CATHETER THROMBOSIS 0/20 (0%) 0/22 (0%) 1/20 (5%)
    MUCOSAL INFLAMMATION 6/20 (30%) 3/22 (13.6%) 3/20 (15%)
    CATHETER SITE ERYTHEMA 1/20 (5%) 0/22 (0%) 0/20 (0%)
    INFLUENZA LIKE ILLNESS 1/20 (5%) 1/22 (4.5%) 0/20 (0%)
    Immune system disorders
    HYPERSENSITIVITY 2/20 (10%) 0/22 (0%) 0/20 (0%)
    Infections and infestations
    INFECTION 0/20 (0%) 0/22 (0%) 1/20 (5%)
    PNEUMONIA 0/20 (0%) 0/22 (0%) 1/20 (5%)
    SINUSITIS 1/20 (5%) 1/22 (4.5%) 2/20 (10%)
    BRONCHITIS 0/20 (0%) 1/22 (4.5%) 1/20 (5%)
    CANDIDIASIS 1/20 (5%) 0/22 (0%) 0/20 (0%)
    NAIL INFECTION 1/20 (5%) 1/22 (4.5%) 1/20 (5%)
    ORAL CANDIDIASIS 1/20 (5%) 0/22 (0%) 0/20 (0%)
    LOCALISED INFECTION 1/20 (5%) 0/22 (0%) 0/20 (0%)
    FUNGAL SKIN INFECTION 0/20 (0%) 0/22 (0%) 1/20 (5%)
    URINARY TRACT INFECTION 1/20 (5%) 1/22 (4.5%) 0/20 (0%)
    NAIL BED INFECTION FUNGAL 1/20 (5%) 0/22 (0%) 0/20 (0%)
    UPPER RESPIRATORY TRACT INFECTION 0/20 (0%) 0/22 (0%) 2/20 (10%)
    Injury, poisoning and procedural complications
    LIMB INJURY 1/20 (5%) 0/22 (0%) 0/20 (0%)
    WOUND SECRETION 0/20 (0%) 0/22 (0%) 1/20 (5%)
    WOUND COMPLICATION 0/20 (0%) 0/22 (0%) 1/20 (5%)
    Investigations
    WEIGHT DECREASED 3/20 (15%) 2/22 (9.1%) 5/20 (25%)
    HAEMOGLOBIN DECREASED 2/20 (10%) 10/22 (45.5%) 5/20 (25%)
    BLOOD GLUCOSE INCREASED 0/20 (0%) 2/22 (9.1%) 0/20 (0%)
    PLATELET COUNT DECREASED 0/20 (0%) 3/22 (13.6%) 1/20 (5%)
    BLOOD CREATININE INCREASED 0/20 (0%) 0/22 (0%) 1/20 (5%)
    EOSINOPHIL COUNT DECREASED 1/20 (5%) 0/22 (0%) 0/20 (0%)
    NEUTROPHIL COUNT DECREASED 3/20 (15%) 2/22 (9.1%) 5/20 (25%)
    EJECTION FRACTION DECREASED 1/20 (5%) 0/22 (0%) 0/20 (0%)
    GRANULOCYTE COUNT DECREASED 1/20 (5%) 0/22 (0%) 1/20 (5%)
    WHITE BLOOD CELL COUNT DECREASED 3/20 (15%) 5/22 (22.7%) 4/20 (20%)
    WHITE BLOOD CELL COUNT INCREASED 1/20 (5%) 0/22 (0%) 0/20 (0%)
    ALANINE AMINOTRANSFERASE INCREASED 0/20 (0%) 1/22 (4.5%) 2/20 (10%)
    ASPARTATE AMINOTRANSFERASE INCREASED 1/20 (5%) 2/22 (9.1%) 3/20 (15%)
    BLOOD ALKALINE PHOSPHATASE INCREASED 0/20 (0%) 3/22 (13.6%) 0/20 (0%)
    Metabolism and nutrition disorders
    DEHYDRATION 0/20 (0%) 4/22 (18.2%) 2/20 (10%)
    HYPOKALAEMIA 2/20 (10%) 6/22 (27.3%) 4/20 (20%)
    HYPERKALAEMIA 0/20 (0%) 0/22 (0%) 1/20 (5%)
    HYPOCALCAEMIA 1/20 (5%) 1/22 (4.5%) 1/20 (5%)
    HYPONATRAEMIA 0/20 (0%) 2/22 (9.1%) 2/20 (10%)
    HYPERGLYCAEMIA 2/20 (10%) 1/22 (4.5%) 3/20 (15%)
    HYPOMAGNESAEMIA 1/20 (5%) 2/22 (9.1%) 1/20 (5%)
    HYPOALBUMINAEMIA 0/20 (0%) 0/22 (0%) 1/20 (5%)
    DECREASED APPETITE 6/20 (30%) 7/22 (31.8%) 6/20 (30%)
    Musculoskeletal and connective tissue disorders
    MYALGIA 0/20 (0%) 3/22 (13.6%) 1/20 (5%)
    BACK PAIN 1/20 (5%) 3/22 (13.6%) 1/20 (5%)
    BONE PAIN 2/20 (10%) 1/22 (4.5%) 2/20 (10%)
    NECK PAIN 0/20 (0%) 0/22 (0%) 1/20 (5%)
    ARTHRALGIA 3/20 (15%) 3/22 (13.6%) 1/20 (5%)
    MUSCLE SPASMS 0/20 (0%) 1/22 (4.5%) 1/20 (5%)
    JOINT STIFFNESS 1/20 (5%) 0/22 (0%) 0/20 (0%)
    PAIN IN EXTREMITY 3/20 (15%) 1/22 (4.5%) 5/20 (25%)
    MUSCULOSKELETAL PAIN 1/20 (5%) 3/22 (13.6%) 3/20 (15%)
    Nervous system disorders
    HEADACHE 4/20 (20%) 3/22 (13.6%) 3/20 (15%)
    MIGRAINE 1/20 (5%) 0/22 (0%) 0/20 (0%)
    DIZZINESS 1/20 (5%) 1/22 (4.5%) 3/20 (15%)
    DYSGEUSIA 2/20 (10%) 3/22 (13.6%) 3/20 (15%)
    PARAESTHESIA 0/20 (0%) 2/22 (9.1%) 1/20 (5%)
    HYPOAESTHESIA 1/20 (5%) 2/22 (9.1%) 0/20 (0%)
    COGNITIVE DISORDER 0/20 (0%) 0/22 (0%) 1/20 (5%)
    NEUROPATHY PERIPHERAL 3/20 (15%) 7/22 (31.8%) 2/20 (10%)
    EXTRAPYRAMIDAL DISORDER 0/20 (0%) 0/22 (0%) 1/20 (5%)
    PERIPHERAL SENSORY NEUROPATHY 3/20 (15%) 8/22 (36.4%) 7/20 (35%)
    Psychiatric disorders
    ANXIETY 3/20 (15%) 3/22 (13.6%) 1/20 (5%)
    INSOMNIA 1/20 (5%) 4/22 (18.2%) 0/20 (0%)
    DEPRESSION 1/20 (5%) 3/22 (13.6%) 2/20 (10%)
    Renal and urinary disorders
    POLLAKIURIA 0/20 (0%) 1/22 (4.5%) 1/20 (5%)
    BLADDER SPASM 0/20 (0%) 0/22 (0%) 1/20 (5%)
    STRESS URINARY INCONTINENCE 1/20 (5%) 0/22 (0%) 0/20 (0%)
    Reproductive system and breast disorders
    BREAST DISCHARGE 0/20 (0%) 0/22 (0%) 1/20 (5%)
    PELVIC HAEMATOMA 0/20 (0%) 0/22 (0%) 1/20 (5%)
    VAGINAL HAEMORRHAGE 0/20 (0%) 0/22 (0%) 1/20 (5%)
    MENSTRUATION IRREGULAR 0/20 (0%) 1/22 (4.5%) 1/20 (5%)
    Respiratory, thoracic and mediastinal disorders
    COUGH 3/20 (15%) 3/22 (13.6%) 2/20 (10%)
    DYSPNOEA 3/20 (15%) 4/22 (18.2%) 4/20 (20%)
    DYSPHONIA 0/20 (0%) 0/22 (0%) 1/20 (5%)
    EPISTAXIS 0/20 (0%) 1/22 (4.5%) 1/20 (5%)
    NASAL CONGESTION 0/20 (0%) 1/22 (4.5%) 1/20 (5%)
    PRODUCTIVE COUGH 1/20 (5%) 1/22 (4.5%) 0/20 (0%)
    SINUS CONGESTION 0/20 (0%) 0/22 (0%) 1/20 (5%)
    RHINITIS ALLERGIC 1/20 (5%) 3/22 (13.6%) 1/20 (5%)
    OROPHARYNGEAL PAIN 0/20 (0%) 1/22 (4.5%) 2/20 (10%)
    PULMONARY EMBOLISM 2/20 (10%) 0/22 (0%) 0/20 (0%)
    Skin and subcutaneous tissue disorders
    RASH 2/20 (10%) 4/22 (18.2%) 2/20 (10%)
    ALOPECIA 4/20 (20%) 10/22 (45.5%) 6/20 (30%)
    DRY SKIN 2/20 (10%) 1/22 (4.5%) 2/20 (10%)
    ERYTHEMA 1/20 (5%) 0/22 (0%) 0/20 (0%)
    PRURITUS 1/20 (5%) 2/22 (9.1%) 2/20 (10%)
    KOILONYCHIA 1/20 (5%) 0/22 (0%) 0/20 (0%)
    ONYCHOLYSIS 1/20 (5%) 0/22 (0%) 0/20 (0%)
    ONYCHOCLASIS 1/20 (5%) 0/22 (0%) 0/20 (0%)
    NAIL DISORDER 4/20 (20%) 2/22 (9.1%) 3/20 (15%)
    ONYCHOMADESIS 1/20 (5%) 0/22 (0%) 0/20 (0%)
    PALMAR ERYTHEMA 1/20 (5%) 0/22 (0%) 1/20 (5%)
    EXFOLIATIVE RASH 0/20 (0%) 0/22 (0%) 1/20 (5%)
    SKIN EXFOLIATION 2/20 (10%) 1/22 (4.5%) 0/20 (0%)
    RASH ERYTHEMATOUS 0/20 (0%) 0/22 (0%) 1/20 (5%)
    RASH MACULO-PAPULAR 0/20 (0%) 0/22 (0%) 1/20 (5%)
    SKIN DISCOLOURATION 1/20 (5%) 0/22 (0%) 1/20 (5%)
    SKIN HYPERPIGMENTATION 0/20 (0%) 1/22 (4.5%) 1/20 (5%)
    PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME 8/20 (40%) 12/22 (54.5%) 8/20 (40%)
    Vascular disorders
    FLUSHING 0/20 (0%) 0/22 (0%) 1/20 (5%)
    HOT FLUSH 0/20 (0%) 3/22 (13.6%) 0/20 (0%)
    HYPOTENSION 1/20 (5%) 1/22 (4.5%) 0/20 (0%)
    LYMPHOEDEMA 1/20 (5%) 1/22 (4.5%) 1/20 (5%)
    HYPERTENSION 1/20 (5%) 0/22 (0%) 1/20 (5%)
    VENOUS THROMBOSIS 1/20 (5%) 0/22 (0%) 0/20 (0%)
    DEEP VEIN THROMBOSIS 1/20 (5%) 0/22 (0%) 0/20 (0%)
    ORTHOSTATIC HYPOTENSION 0/20 (0%) 0/22 (0%) 1/20 (5%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

    Results Point of Contact

    Name/Title BMS Study Director
    Organization Bristol-Myers Squibb
    Phone
    Email Clinical.Trials@bms.com
    Responsible Party:
    R-Pharm
    ClinicalTrials.gov Identifier:
    NCT00546364
    Other Study ID Numbers:
    • CA163-131
    First Posted:
    Oct 18, 2007
    Last Update Posted:
    Mar 10, 2016
    Last Verified:
    Feb 1, 2016