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Cisplatin, Irinotecan and Bevacizumab (PCA) Versus Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00911820
Collaborator
Massachusetts General Hospital (Other), SCRI Development Innovations, LLC (Other), Texas Oncology Cancer Center (Industry), Genentech, Inc. (Industry)
88
Enrollment
4
Locations
2
Arms
149
Anticipated Duration (Months)
22
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There is no clear standard of care for metastatic stomach or esophageal cancer in the United States. The purpose of this research study is to determine the differences between two regimens of chemotherapy; Arm A: PCA (Cisplatin, Irinotecan and Bevacizumab) and Arm B: TPCA (Docetaxel, Cisplatin, Irinotecan and Bevacizumab). Docetaxel, Cisplatin, and Irinotecan are traditional chemotherapy drugs. Bevacizumab is an antibody (a protein that attacks a foreign substance in the body). Bevacizumab is believed to stop the formation of new blood vessels that carry nutrients to tumors. Both of the chemotherapy regimens (PCA and TPCA) have been studied in patients with esophageal and gastric cancer, and we are trying to determine if one regimen will keep your cancer from growing and improve how long you can live.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

Primary

  • To evaluate progression-free survival at 7 months in metastatic esophageal and gastric patients treated with either PCA or TPCA

Secondary

  • To determine overall survival

  • To determine the response rate (RECIST) in measurable disease patients

  • To evaluate type and severity of toxicities associated with each regimen

Exploratory:

  • To correlate expression of tumoral and serum VEGF with response and survival

  • To correlate TGF alpha levels and tumor microvessel density with clinical activity of the combination of PCA or TPCA

  • To examine circulating endothelial cells (CECs) as surrogate markers of antitumor activity of bevacizumab

  • To explore if 7/7 and 7/6 UGT1A1 polymorphisms correlate with grade III/IV irinotecan-related diarrhea and neutropenia when irinotecan is given at relatively low dose to patients with esophageal and gastric cancer

DESIGN:

This trial was designed to compare 7-month progression-free survival between arms. The hypothesis was that TPCA would have superior outcome over PCA (70% vs 50%). With 40 eligible patients per arm followed for 1 year there was 80% power to detect a hazard ratio of 0.48 using the log-rank test at a one-sided type I error rate of 5%. Stratification factors were ECOG performance status 0/1 vs 2 and site of primary tumor (gastric vs GE junction/esophageal).

Study Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Multicenter, Phase II Trial of Cisplatin, Irinotecan and Bevacizumab (PCA) vs. Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
Actual Study Start Date :
Jul 1, 2009
Actual Primary Completion Date :
Apr 1, 2012
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm A: PCA

Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.

Drug: Bevacizumab
Other Names:
  • Avastin

    • Drug: Cisplatin
    Other Names:
  • Platinol-AQ
  • Platinol

    • Drug: Irinotecan
    Other Names:
  • Camptosar

    		•
    Active Comparator: Arm B: TPCA

    Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.

    Drug: Cisplatin
    Other Names:
  • Platinol-AQ
  • Platinol

    • Drug: Irinotecan
    Other Names:
  • Camptosar

    • Device: Docetaxel
    Other Names:
  • Taxotere
  • Docefrez

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 7-month Progression-Free Survival [Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Relevant for this endpoint was disease status at 7 months of follow-up.]

      7-month progression-free survival is the probability of patients remaining alive and progression-free at 7-months from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.

    Secondary Outcome Measures

    1. Overall Survival [Patients in the study cohort were followed up to approximately 2.5 years as of this analysis.]

      Overall survival is defined as the time from study entry to death or date last known alive and estimate using Kaplan-Meier (KM) methods.

    2. Best Response [Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment duration was a median of 5 cycles (up to approximately 1 year) in this study cohort as of this analysis..]

      Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria.

    3. Overall Response (OR) Rate [Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment duration was a median of 5 cycles (up to approximately 1 year) in this study cohort as of this analysis.]

      Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

    4. Progression-Free Survival [Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Patients were followed for up to 2.5 years as of this analysis.]

      Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Patients alive and progression-free at last follow-up are censored. Per RECIST 1.0 criteria: progressive disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.

    Eligibility Criteria

    Criteria

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

    • Histologically confirmed, unresectable esophageal, GE junction or gastric adenocarcinoma (including adenosquamous, or undifferentiated carcinoma). Measurable disease is not required.

    • 18 years of age or older

    • ECOG Performance Status=2

    • Life expectancy of 12 weeks or greater

    • Adequate bone marrow, renal and liver function as outlined in the protocol.

    • Men and women of childbearing potential must use adequate contraception

    Exclusion Criteria:

    • Prior chemotherapy (except as part of pre- or post-operative therapy, completed at least 1 prior to start of this protocol).

    • Squamous cell carcinoma histology of esophageal, GE junction or gastric tumor

    • Known history of allergy or hypersensitivity to Chinese hamster ovary products, polysorbate 80, or any of the study drugs

    • Treatment or planned participation in an experimental drug study within 4 weeks of C1 D1. Concurrent use of herbal medications or other alternative therapies

    • Major surgical procedures, such as fine needle aspirations, port-a-cath placement, or core biopsies, within 7 days of cycle 1 day 1

    • Palliative radiation to 25% or less of bone marrow, must be completed > 2 weeks prior to day 1, palliative radiation to > 25% of bone marrow, must be completed > 4 weeks prior to day 1

    • Myocardial infarction, unstable angina, CVA or TIA or other thrombotic event in the past six months

    • Inadequately controlled hypertension (defined as systolic blood pressure of >150mmHg and/or diastolic blood pressure of > 100mmHg). Initiation of antihypertensive medication is recommended, however adequate control of blood pressure must be documented prior to C1 D1

    • No history of prior hypertensive crisis or hypertensive encephalopathy

    • NYHA Grade II or greater congestive heart failure

    • Clinically significant peripheral vascular disease

    • Active bleeding from primary tumor

    • Evidence of bleeding diatheses or coagulopathy (other than deep venous thrombosis, portal vein thrombosis, pulmonary embolism, or atrial fibrillation). Patients on therapeutic anticoagulation may be enrolled provided they have been clinically stable on anticoagulation for a least 2 weeks prior to C1 D1.

    • Uncontrolled serious medical or psychiatric illness

    • Uncontrolled diarrhea

    • Peripheral neuropathy

    • No known brain or other CNS metastasis by history or clinical examination

    • Other active malignancy other than non-melanoma skin cancer or in-situ cervical carcinoma. A resected or previously treated cancer (other than in-situ carcinoma) must have demonstrated no evidence of recurrence for at least 3 years

    • Urine protein:creatinine ratio 1.0 or greater at screening

    • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess with 6 months of C1 D1

    • Serious, non-healing wound, ulcer or bone fracture

    • Pregnant or breast feeding

    • Inability to comply with study and/or follow-up procedures

    • History of HIV seropositivity, hepatitis C virus, acute or chronic hepatitis B, or other serious chronic infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
    2 Massachusetts General Hospital Boston Massachusetts United States 02214
    3 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    4 Texas Oncology Research Dallas Texas United States 75251

    Sponsors and Collaborators

    • Dana-Farber Cancer Institute
    • Massachusetts General Hospital
    • SCRI Development Innovations, LLC
    • Texas Oncology Cancer Center
    • Genentech, Inc.

    Investigators

    • Principal Investigator: Peter C. Enzinger, MD, Dana-Farber Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peter C. Enzinger, MD, Principal Investigator, Dana-Farber Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT00911820
    Other Study ID Numbers:
    • 09-039
    First Posted:
    Jun 2, 2009
    Last Update Posted:
    Jul 9, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Bevacizumab
    Cisplatin
    Docetaxel
    Irinotecan

    Study Results

    Participant Flow

    Recruitment Details Patients were enrolled between July 2009 and April 2011.
    Pre-assignment Detail
    Arm/Group Title Arm A: PCA Arm B: TPCA
    Arm/Group Description Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity. Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
    Period Title: Overall Study
    STARTED 45 43
    Treated 44 41
    COMPLETED 0 0
    NOT COMPLETED 45 43

    Baseline Characteristics

    Arm/Group Title Arm A: PCA Arm B: TPCA Total
    Arm/Group Description Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity. Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle. Total of all reporting groups
    Overall Participants 44 41 85
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    59
    61
    60
    Sex: Female, Male (Count of Participants)
    Female
    8
    18.2%
    7
    17.1%
    15
    17.6%
    Male
    36
    81.8%
    34
    82.9%
    70
    82.4%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    2
    4.5%
    0
    0%
    2
    2.4%
    White
    41
    93.2%
    39
    95.1%
    80
    94.1%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    1
    2.3%
    2
    4.9%
    3
    3.5%
    Region of Enrollment (Count of Participants)
    United States
    44
    100%
    41
    100%
    85
    100%
    ECOG Performance Status (PS) (Count of Participants)
    ECOG PS 0/1
    43
    97.7%
    40
    97.6%
    83
    97.6%
    ECOG PS 2
    1
    2.3%
    1
    2.4%
    2
    2.4%
    Tumor Location (Count of Participants)
    Esophagus
    20
    45.5%
    17
    41.5%
    37
    43.5%
    GE Junction
    9
    20.5%
    12
    29.3%
    21
    24.7%
    Gastric
    15
    34.1%
    12
    29.3%
    27
    31.8%

    Outcome Measures

    1. Primary Outcome
    Title 7-month Progression-Free Survival
    Description 7-month progression-free survival is the probability of patients remaining alive and progression-free at 7-months from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
    Time Frame Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Relevant for this endpoint was disease status at 7 months of follow-up.

    Outcome Measure Data

    Analysis Population Description
    The analysis dataset is comprised of all treated patients.
    Arm/Group Title Arm A: PCA Arm B: TPCA
    Arm/Group Description Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity. Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
    Measure Participants 44 41
    Number (95% Confidence Interval) [probability]
    0.581
    0.582
    2. Secondary Outcome
    Title Overall Survival
    Description Overall survival is defined as the time from study entry to death or date last known alive and estimate using Kaplan-Meier (KM) methods.
    Time Frame Patients in the study cohort were followed up to approximately 2.5 years as of this analysis.

    Outcome Measure Data

    Analysis Population Description
    The analysis dataset is comprised of all treated patients.
    Arm/Group Title Arm A: PCA Arm B: TPCA
    Arm/Group Description Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity. Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
    Measure Participants 44 41
    Median (95% Confidence Interval) [months]
    11.7
    13.4
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm A: PCA, Arm B: TPCA
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.714
    Comments
    Method Log Rank
    Comments
    3. Secondary Outcome
    Title Best Response
    Description Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria.
    Time Frame Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment duration was a median of 5 cycles (up to approximately 1 year) in this study cohort as of this analysis..

    Outcome Measure Data

    Analysis Population Description
    The analysis dataset is comprised of all treated patients.
    Arm/Group Title Arm A: PCA Arm B: TPCA
    Arm/Group Description Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity. Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
    Measure Participants 44 41
    Complete Response
    3
    6.8%
    0
    0%
    Partial Response
    22
    50%
    21
    51.2%
    Stable Disease
    15
    34.1%
    14
    34.1%
    Progressive Disease
    1
    2.3%
    0
    0%
    Removed Before Restaging
    3
    6.8%
    6
    14.6%
    4. Secondary Outcome
    Title Overall Response (OR) Rate
    Description Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
    Time Frame Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment duration was a median of 5 cycles (up to approximately 1 year) in this study cohort as of this analysis.

    Outcome Measure Data

    Analysis Population Description
    The analysis dataset is comprised of all treated patients.
    Arm/Group Title Arm A: PCA Arm B: TPCA
    Arm/Group Description Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity. Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
    Measure Participants 44 41
    Number (95% Confidence Interval) [proportion of patients]
    .568
    .512
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm A: PCA, Arm B: TPCA
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.605
    Comments
    Method Fisher Exact
    Comments
    5. Secondary Outcome
    Title Progression-Free Survival
    Description Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Patients alive and progression-free at last follow-up are censored. Per RECIST 1.0 criteria: progressive disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
    Time Frame Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Patients were followed for up to 2.5 years as of this analysis.

    Outcome Measure Data

    Analysis Population Description
    The analysis dataset is comprised of all treated patients.
    Arm/Group Title Arm A: PCA Arm B: TPCA
    Arm/Group Description Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity. Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
    Measure Participants 44 41
    Median (95% Confidence Interval) [months]
    7.9
    8.4
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm A: PCA, Arm B: TPCA
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.721
    Comments
    Method Log Rank
    Comments

    Adverse Events

    Time Frame Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
    Adverse Event Reporting Description Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
    Arm/Group Title Arm A: PCA Arm B: TPCA
    Arm/Group Description Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity. Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
    All Cause Mortality
    Arm A: PCA Arm B: TPCA
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/44 (0%) 3/41 (7.3%)
    Serious Adverse Events
    Arm A: PCA Arm B: TPCA
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 32/44 (72.7%) 36/41 (87.8%)
    Blood and lymphatic system disorders
    Febrile neutropenia 1/44 (2.3%) 3/41 (7.3%)
    Hematologic-other 0/44 (0%) 1/41 (2.4%)
    Hemoglobin 5/44 (11.4%) 3/41 (7.3%)
    Cardiac disorders
    Cardiac-ischemia 1/44 (2.3%) 0/41 (0%)
    Ear and labyrinth disorders
    Tinnitus 1/44 (2.3%) 0/41 (0%)
    Gastrointestinal disorders
    Abdomen, pain 0/44 (0%) 2/41 (4.9%)
    Colitis 0/44 (0%) 1/41 (2.4%)
    Diarrhea w/o prior colostomy 10/44 (22.7%) 13/41 (31.7%)
    Dysphagia 0/44 (0%) 1/41 (2.4%)
    Enteritis 0/44 (0%) 1/41 (2.4%)
    Esophagus, hemorrhage 0/44 (0%) 1/41 (2.4%)
    GI-other 1/44 (2.3%) 1/41 (2.4%)
    Ileum, hemorrhage 0/44 (0%) 1/41 (2.4%)
    Nausea 4/44 (9.1%) 5/41 (12.2%)
    Perforation, colon 0/44 (0%) 2/41 (4.9%)
    Upper GI, hemorrhage NOS 2/44 (4.5%) 0/41 (0%)
    Vomiting 4/44 (9.1%) 5/41 (12.2%)
    General disorders
    Death - sudden death 0/44 (0%) 1/41 (2.4%)
    Extremity-lower (gait/walking) 1/44 (2.3%) 0/41 (0%)
    Fatigue 7/44 (15.9%) 9/41 (22%)
    Immune system disorders
    Allergic reaction 0/44 (0%) 1/41 (2.4%)
    Infections and infestations
    Infection Gr0-2 neut, esophagus 1/44 (2.3%) 0/41 (0%)
    Infection Gr0-2 neut, sinus 0/44 (0%) 1/41 (2.4%)
    Infection w/ gr 3-4 neut, blood 1/44 (2.3%) 0/41 (0%)
    Infection w/ gr3-4 neut, lung 1/44 (2.3%) 0/41 (0%)
    Infection w/ gr3-4 neut, upper airway 0/44 (0%) 1/41 (2.4%)
    Infection w/ gr3-4 neut, wound 1/44 (2.3%) 0/41 (0%)
    Infection w/ unk ANC appendix 0/44 (0%) 1/41 (2.4%)
    Infection-other 1/44 (2.3%) 0/41 (0%)
    Injury, poisoning and procedural complications
    Leak, incl. anastomotic, small bowel 0/44 (0%) 1/41 (2.4%)
    Vascular access,Thrombosis/embolism 1/44 (2.3%) 1/41 (2.4%)
    Investigations
    Cardiac troponin I (cTnI) 1/44 (2.3%) 0/41 (0%)
    Leukocytes 6/44 (13.6%) 11/41 (26.8%)
    Lymphopenia 4/44 (9.1%) 6/41 (14.6%)
    Neutrophils 11/44 (25%) 13/41 (31.7%)
    Platelets 2/44 (4.5%) 2/41 (4.9%)
    Metabolism and nutrition disorders
    Anorexia 1/44 (2.3%) 4/41 (9.8%)
    Dehydration 6/44 (13.6%) 5/41 (12.2%)
    Hyperglycemia 1/44 (2.3%) 3/41 (7.3%)
    Hypernatremia 0/44 (0%) 1/41 (2.4%)
    Hypocalcemia 1/44 (2.3%) 0/41 (0%)
    Hypokalemia 0/44 (0%) 1/41 (2.4%)
    Hyponatremia 1/44 (2.3%) 5/41 (12.2%)
    Hypophosphatemia 0/44 (0%) 2/41 (4.9%)
    Musculoskeletal and connective tissue disorders
    Back, pain 0/44 (0%) 1/41 (2.4%)
    Nervous system disorders
    CNS cerebrovascular ischemia 1/44 (2.3%) 0/41 (0%)
    Dizziness 1/44 (2.3%) 0/41 (0%)
    Head/headache 1/44 (2.3%) 1/41 (2.4%)
    Respiratory, thoracic and mediastinal disorders
    Nose, hemorrhage 0/44 (0%) 1/41 (2.4%)
    Pulmonary/Upper Respiratory-other 2/44 (4.5%) 1/41 (2.4%)
    Vascular disorders
    Hemorrhage-other 1/44 (2.3%) 0/41 (0%)
    Hypertension 2/44 (4.5%) 2/41 (4.9%)
    Hypotension 0/44 (0%) 1/41 (2.4%)
    Thrombosis/thrombus/embolism 1/44 (2.3%) 3/41 (7.3%)
    Other (Not Including Serious) Adverse Events
    Arm A: PCA Arm B: TPCA
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 44/44 (100%) 39/41 (95.1%)
    Blood and lymphatic system disorders
    Febrile neutropenia 0/44 (0%) 2/41 (4.9%)
    Hematologic-other 1/44 (2.3%) 0/41 (0%)
    Hemoglobin 34/44 (77.3%) 28/41 (68.3%)
    Cardiac disorders
    Atrial fibrillation 0/44 (0%) 2/41 (4.9%)
    Cardiac-other 2/44 (4.5%) 2/41 (4.9%)
    Palpitations 1/44 (2.3%) 1/41 (2.4%)
    Pericardial effusion (non-malignant) 1/44 (2.3%) 0/41 (0%)
    Pericarditis 1/44 (2.3%) 0/41 (0%)
    Sinus bradycardia 0/44 (0%) 1/41 (2.4%)
    Ear and labyrinth disorders
    Hearing-other 1/44 (2.3%) 0/41 (0%)
    Middle ear, pain 0/44 (0%) 2/41 (4.9%)
    Tinnitus 2/44 (4.5%) 0/41 (0%)
    Endocrine disorders
    Endocrine-other 1/44 (2.3%) 0/41 (0%)
    Eye disorders
    Cataract 1/44 (2.3%) 0/41 (0%)
    Double vision 1/44 (2.3%) 0/41 (0%)
    Ocular-other 1/44 (2.3%) 1/41 (2.4%)
    Tearing 0/44 (0%) 3/41 (7.3%)
    Vision-blurred 5/44 (11.4%) 1/41 (2.4%)
    Vision-flashing lights/floaters 1/44 (2.3%) 0/41 (0%)
    Gastrointestinal disorders
    Abdomen, pain 17/44 (38.6%) 19/41 (46.3%)
    Anus, hemorrhage 1/44 (2.3%) 0/41 (0%)
    Chelitis 1/44 (2.3%) 0/41 (0%)
    Colitis 0/44 (0%) 1/41 (2.4%)
    Colon, hemorrhage 0/44 (0%) 1/41 (2.4%)
    Constipation 21/44 (47.7%) 18/41 (43.9%)
    Diarrhea w/o prior colostomy 31/44 (70.5%) 29/41 (70.7%)
    Distention/bloating, abdominal 0/44 (0%) 2/41 (4.9%)
    Dry mouth 1/44 (2.3%) 1/41 (2.4%)
    Dyspepsia 7/44 (15.9%) 6/41 (14.6%)
    Dysphagia 11/44 (25%) 5/41 (12.2%)
    Esophagitis 2/44 (4.5%) 1/41 (2.4%)
    Esophagus, hemorrhage 1/44 (2.3%) 0/41 (0%)
    Esophagus, pain 3/44 (6.8%) 2/41 (4.9%)
    Flatulence 5/44 (11.4%) 3/41 (7.3%)
    Gastritis 2/44 (4.5%) 1/41 (2.4%)
    GI-other 6/44 (13.6%) 9/41 (22%)
    Hemorrhoids 1/44 (2.3%) 1/41 (2.4%)
    Ileus 0/44 (0%) 1/41 (2.4%)
    Lip, pain 1/44 (2.3%) 0/41 (0%)
    Muco/stomatitis (symptom) oral cavity 1/44 (2.3%) 5/41 (12.2%)
    Muco/stomatitis by exam, oral cavity 1/44 (2.3%) 5/41 (12.2%)
    Nausea 35/44 (79.5%) 31/41 (75.6%)
    Obstruction, small bowel NOS 1/44 (2.3%) 0/41 (0%)
    Oral cavity, hemorrhage 1/44 (2.3%) 0/41 (0%)
    Oral cavity, pain 0/44 (0%) 3/41 (7.3%)
    Oral gums, pain 0/44 (0%) 2/41 (4.9%)
    Perforation, colon 0/44 (0%) 2/41 (4.9%)
    Perforation, stomach 0/44 (0%) 1/41 (2.4%)
    Periodontal disease 0/44 (0%) 1/41 (2.4%)
    Rectum, hemorrhage 4/44 (9.1%) 2/41 (4.9%)
    Rectum, pain 1/44 (2.3%) 0/41 (0%)
    Stenosis (incl anastomotic) esophagus 0/44 (0%) 1/41 (2.4%)
    Stomach, pain 8/44 (18.2%) 3/41 (7.3%)
    Teeth 0/44 (0%) 1/41 (2.4%)
    Ulcer, cecum 0/44 (0%) 1/41 (2.4%)
    Ulcer, colon 0/44 (0%) 1/41 (2.4%)
    Ulcer, esophagus 0/44 (0%) 1/41 (2.4%)
    Ulcer, gastric 0/44 (0%) 1/41 (2.4%)
    Vomiting 22/44 (50%) 21/41 (51.2%)
    General disorders
    Chest/thoracic pain NOS 5/44 (11.4%) 3/41 (7.3%)
    Constitutional, other 0/44 (0%) 1/41 (2.4%)
    Edema head and neck 0/44 (0%) 1/41 (2.4%)
    Edema limb 5/44 (11.4%) 3/41 (7.3%)
    Extremity-lower (gait/walking) 1/44 (2.3%) 0/41 (0%)
    Fatigue 35/44 (79.5%) 34/41 (82.9%)
    Fever w/o neutropenia 3/44 (6.8%) 5/41 (12.2%)
    Injection site reaction 0/44 (0%) 1/41 (2.4%)
    Pain-other 4/44 (9.1%) 6/41 (14.6%)
    Rigors/chills 4/44 (9.1%) 2/41 (4.9%)
    Immune system disorders
    Allergic reaction 1/44 (2.3%) 5/41 (12.2%)
    Allergy-other 1/44 (2.3%) 0/41 (0%)
    Infections and infestations
    Infection Gr0-2 neut, anal/perianl 0/44 (0%) 1/41 (2.4%)
    Infection Gr0-2 neut, catheter 1/44 (2.3%) 1/41 (2.4%)
    Infection Gr0-2 neut, dental-tooth 1/44 (2.3%) 2/41 (4.9%)
    Infection Gr0-2 neut, esophagus 0/44 (0%) 1/41 (2.4%)
    Infection Gr0-2 neut, external ear 0/44 (0%) 1/41 (2.4%)
    Infection Gr0-2 neut, foreign body 1/44 (2.3%) 1/41 (2.4%)
    Infection Gr0-2 neut, oral cavity 0/44 (0%) 0/41 (0%)
    Infection Gr0-2 neut, sinus 2/44 (4.5%) 0/41 (0%)
    Infection Gr0-2 neut, skin 0/44 (0%) 2/41 (4.9%)
    Infection Gr0-2 neut, ungual 0/44 (0%) 1/41 (2.4%)
    Infection Gr0-2 neut, upper airway 1/44 (2.3%) 2/41 (4.9%)
    Infection Gr0-2 neut, vagina 1/44 (2.3%) 0/41 (0%)
    Infection w/ gr3-4 neut, paranasal 0/44 (0%) 1/41 (2.4%)
    Infection w/ unk ANC colon 0/44 (0%) 1/41 (2.4%)
    Infection w/ unk ANC lung 1/44 (2.3%) 0/41 (0%)
    Infection w/ unk ANC prostate 0/44 (0%) 1/41 (2.4%)
    Infection w/ unk ANC sinus 1/44 (2.3%) 0/41 (0%)
    Infection w/ unk ANC skin (cellulitis) 1/44 (2.3%) 0/41 (0%)
    Infection w/ unk ANC stomach 1/44 (2.3%) 0/41 (0%)
    Infection w/ unk ANC upper airway NOS 1/44 (2.3%) 0/41 (0%)
    Infection w/ unk ANC urinary tract NOS 1/44 (2.3%) 0/41 (0%)
    Infection w/ unk ANC vagina 1/44 (2.3%) 0/41 (0%)
    Infection-other 2/44 (4.5%) 2/41 (4.9%)
    Injury, poisoning and procedural complications
    Bruising 1/44 (2.3%) 1/41 (2.4%)
    Leak, incl. anastomotic, esophagitis 1/44 (2.3%) 0/41 (0%)
    Leak, incl. anastomotic, small bowel 0/44 (0%) 2/41 (4.9%)
    Ulcer, stoma 0/44 (0%) 1/41 (2.4%)
    Vascular access,Thrombosis/embolism 0/44 (0%) 1/41 (2.4%)
    Wound - non-infectious 0/44 (0%) 2/41 (4.9%)
    Investigations
    Alkaline phosphatase 5/44 (11.4%) 5/41 (12.2%)
    ALT, SGPT 1/44 (2.3%) 6/41 (14.6%)
    AST, SGOT 3/44 (6.8%) 2/41 (4.9%)
    Bilirubin 1/44 (2.3%) 3/41 (7.3%)
    Coagulation-other 0/44 (0%) 2/41 (4.9%)
    Creatinine 12/44 (27.3%) 5/41 (12.2%)
    Hypercholesterolemia 0/44 (0%) 1/41 (2.4%)
    INR 0/44 (0%) 1/41 (2.4%)
    Leukocytes 23/44 (52.3%) 23/41 (56.1%)
    Lymphopenia 6/44 (13.6%) 6/41 (14.6%)
    Metabolic/Laboratory-other 0/44 (0%) 1/41 (2.4%)
    Neutrophils 19/44 (43.2%) 17/41 (41.5%)
    Platelets 23/44 (52.3%) 17/41 (41.5%)
    PTT 0/44 (0%) 2/41 (4.9%)
    Weight gain 1/44 (2.3%) 0/41 (0%)
    Weight loss 15/44 (34.1%) 13/41 (31.7%)
    Metabolism and nutrition disorders
    Anorexia 19/44 (43.2%) 28/41 (68.3%)
    Bicarbonate 1/44 (2.3%) 1/41 (2.4%)
    Dehydration 15/44 (34.1%) 14/41 (34.1%)
    Hyperglycemia 20/44 (45.5%) 18/41 (43.9%)
    Hyperkalemia 10/44 (22.7%) 11/41 (26.8%)
    Hypermagnesemia 1/44 (2.3%) 0/41 (0%)
    Hypernatremia 1/44 (2.3%) 1/41 (2.4%)
    Hypertriglyceridemia 3/44 (6.8%) 0/41 (0%)
    Hypoalbuminemia 7/44 (15.9%) 13/41 (31.7%)
    Hypocalcemia 9/44 (20.5%) 15/41 (36.6%)
    Hypoglycemia 5/44 (11.4%) 3/41 (7.3%)
    Hypokalemia 10/44 (22.7%) 10/41 (24.4%)
    Hypomagnesemia 13/44 (29.5%) 16/41 (39%)
    Hyponatremia 15/44 (34.1%) 14/41 (34.1%)
    Hypophosphatemia 2/44 (4.5%) 5/41 (12.2%)
    Musculoskeletal and connective tissue disorders
    Arthritis 0/44 (0%) 1/41 (2.4%)
    Back, pain 7/44 (15.9%) 4/41 (9.8%)
    Bone, pain 2/44 (4.5%) 0/41 (0%)
    Buttock, pain 1/44 (2.3%) 0/41 (0%)
    Chest wall, pain 5/44 (11.4%) 2/41 (4.9%)
    Extremity-limb, pain 3/44 (6.8%) 3/41 (7.3%)
    Joint, pain 5/44 (11.4%) 2/41 (4.9%)
    Muscle, pain 2/44 (4.5%) 2/41 (4.9%)
    Muscular/skeletal hypoplasia 1/44 (2.3%) 0/41 (0%)
    Musculoskeletal/soft tissue-other 3/44 (6.8%) 4/41 (9.8%)
    Neck, pain 1/44 (2.3%) 2/41 (4.9%)
    Nonneuropathic lower extr muscle weak 0/44 (0%) 2/41 (4.9%)
    Nonneuropathic generalized weakness 2/44 (4.5%) 9/41 (22%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Secondary malignancy 0/44 (0%) 1/41 (2.4%)
    Nervous system disorders
    Dizziness 12/44 (27.3%) 10/41 (24.4%)
    Head/headache 18/44 (40.9%) 12/41 (29.3%)
    Memory impairment 1/44 (2.3%) 1/41 (2.4%)
    Mental status 1/44 (2.3%) 1/41 (2.4%)
    Neurologic-other 1/44 (2.3%) 2/41 (4.9%)
    Neuropathy CN I smell 0/44 (0%) 1/41 (2.4%)
    Neuropathy CN V jaw / face-sensory 0/44 (0%) 1/41 (2.4%)
    Neuropathy CN VII face-motor / taste 0/44 (0%) 1/41 (2.4%)
    Neuropathy-motor 0/44 (0%) 1/41 (2.4%)
    Neuropathy-sensory 8/44 (18.2%) 13/41 (31.7%)
    Speech impairment 1/44 (2.3%) 0/41 (0%)
    Syncope 0/44 (0%) 1/41 (2.4%)
    Taste disturbance 8/44 (18.2%) 15/41 (36.6%)
    Tremor 1/44 (2.3%) 6/41 (14.6%)
    Psychiatric disorders
    Agitation 2/44 (4.5%) 1/41 (2.4%)
    Anxiety 9/44 (20.5%) 10/41 (24.4%)
    Confusion 2/44 (4.5%) 1/41 (2.4%)
    Depression 6/44 (13.6%) 6/41 (14.6%)
    Insomnia 8/44 (18.2%) 10/41 (24.4%)
    Libido 0/44 (0%) 1/41 (2.4%)
    Renal and urinary disorders
    Cystitis 1/44 (2.3%) 0/41 (0%)
    Kidney, hemorrhage 0/44 (0%) 1/41 (2.4%)
    Proteinuria 1/44 (2.3%) 2/41 (4.9%)
    Renal failure 0/44 (0%) 1/41 (2.4%)
    Renal/GU-other 0/44 (0%) 2/41 (4.9%)
    Urinary frequency/urgency 1/44 (2.3%) 4/41 (9.8%)
    Urinary retention 2/44 (4.5%) 0/41 (0%)
    Reproductive system and breast disorders
    Irregular menses 0/44 (0%) 1/41 (2.4%)
    Pelvic, pain 1/44 (2.3%) 1/41 (2.4%)
    Vaginal mucositis 1/44 (2.3%) 0/41 (0%)
    Respiratory, thoracic and mediastinal disorders
    Allergic rhinitis 3/44 (6.8%) 7/41 (17.1%)
    Aspiration 0/44 (0%) 1/41 (2.4%)
    Bronchospasm, wheezing 1/44 (2.3%) 1/41 (2.4%)
    Cough 10/44 (22.7%) 7/41 (17.1%)
    Dyspnea 12/44 (27.3%) 9/41 (22%)
    Hiccoughs 5/44 (11.4%) 2/41 (4.9%)
    Lung, hemorrhage 1/44 (2.3%) 0/41 (0%)
    Muco/stomatitis (symptom) larynx 1/44 (2.3%) 0/41 (0%)
    Nasal cavity/paranasal sinus reaction 2/44 (4.5%) 3/41 (7.3%)
    Nose, hemorrhage 16/44 (36.4%) 17/41 (41.5%)
    Pleura, pain 2/44 (4.5%) 0/41 (0%)
    Pleural effusion (non-malignant) 1/44 (2.3%) 0/41 (0%)
    Pneumothorax 1/44 (2.3%) 0/41 (0%)
    Pulmonary/Upper Respiratory-other 6/44 (13.6%) 1/41 (2.4%)
    Throat/pharynx/larynx, pain 3/44 (6.8%) 5/41 (12.2%)
    Voice changes/dysarthria 4/44 (9.1%) 6/41 (14.6%)
    Skin and subcutaneous tissue disorders
    Alopecia 11/44 (25%) 17/41 (41.5%)
    Dry skin 1/44 (2.3%) 7/41 (17.1%)
    Erythema multiforme 0/44 (0%) 2/41 (4.9%)
    Hand-foot reaction 0/44 (0%) 1/41 (2.4%)
    Hyperpigmentation 0/44 (0%) 1/41 (2.4%)
    Nail changes 1/44 (2.3%) 4/41 (9.8%)
    Petechiae 0/44 (0%) 1/41 (2.4%)
    Pruritus/itching 2/44 (4.5%) 2/41 (4.9%)
    Rash/desquamation 1/44 (2.3%) 6/41 (14.6%)
    Rash: acne/acneiform 1/44 (2.3%) 1/41 (2.4%)
    Skin-other 3/44 (6.8%) 1/41 (2.4%)
    Sweating 3/44 (6.8%) 3/41 (7.3%)
    Ulceration 0/44 (0%) 1/41 (2.4%)
    Vascular disorders
    Flushing 1/44 (2.3%) 1/41 (2.4%)
    Hematoma 2/44 (4.5%) 1/41 (2.4%)
    Hemorrhage-other 1/44 (2.3%) 1/41 (2.4%)
    Hot flashes 1/44 (2.3%) 2/41 (4.9%)
    Hypertension 14/44 (31.8%) 7/41 (17.1%)
    Hypotension 5/44 (11.4%) 1/41 (2.4%)
    Phlebitis 0/44 (0%) 1/41 (2.4%)
    Thrombosis/thrombus/embolism 1/44 (2.3%) 0/41 (0%)
    Vascular-Other 0/44 (0%) 1/41 (2.4%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Peter Enzinger, MD
    Organization Dana-Farber Cancer Insitute
    Phone 617-632-6855
    Email Peter_Enzinger@dfci.harvard.edu
    Responsible Party:
    Peter C. Enzinger, MD, Principal Investigator, Dana-Farber Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT00911820
    Other Study ID Numbers:
    • 09-039
    First Posted:
    Jun 2, 2009
    Last Update Posted:
    Jul 9, 2021
    Last Verified:
    Jul 1, 2021