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

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00394433
Collaborator
Brigham and Women's Hospital (Other), Massachusetts General Hospital (Other), Genentech, Inc. (Industry)
38
3
1
121
12.7
0.1

Study Details

Study Description

Brief Summary

The purpose of this research study is to determine if the combination of docetaxel, cisplatin, irinotecan and bevacizumab will help shrink metastatic esophageal or gastric cancer and how the cancer responds to this combination. Bevacizumab is a new drug that is believed to stop the formation of new blood vessels that carry nutrients to tumors. Bevacizumab is approved for use in metastatic colon and rectal cancer. Docetaxel, cisplatin and irinotecan are traditional chemotherapy agents that have been tested together in another clinical trial for esophageal and gastric cancer. It is hoped that adding bevacizumab to this regimen will make the treatment more effective.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

Primary

To determine the 10-month progression-free survival rate for the combination of TPC and Bevacizumab in patients with metastatic esophageal or gastric cancer

Secondary

  • To determine the response rate (RECIST) and median duration of response

  • To determine overall survival

  • To determine toxicity

Exploratory

  • 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

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

  • To correlate TGF alpha levels and tumor microvessel density with clinical activity

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

DESIGN This trial will use a single stage design to differentiate a >/= 50% rate of 10-month progression-free survival from a </= 30% rate. The proposed regimen would be promising if at least 15 of 35 patients were alive and progression-free at 10 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
Study Start Date :
Sep 1, 2006
Actual Primary Completion Date :
Nov 1, 2008
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)

Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.

Drug: Bevacizumab
Other Names:
  • Avastin
  • Drug: Docetaxel
    Other Names:
  • Taxotere, Docefrez
  • Drug: Cisplatin
    Other Names:
  • Platinol-AQ, Platinol
  • Drug: Irinotecan
    Other Names:
  • Camptosar
  • Outcome Measures

    Primary Outcome Measures

    1. 10-month Progression-Free Survival Rate [Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 10 months.]

      10-month progression-free survival rate is the probability of patients remaining alive and progression-free at 10-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. Best Response [Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).]

      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.

    2. Overall Survival [Patients in the study cohort were followed for a median of 12.2 month (up to 40 months).]

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

    3. Progression-Free Survival [Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).]

      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 or gastric carcinoma (carcinoma=adenocarcinoma or squamous cell carcinoma)

    • Measurable disease greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan or 2 cm or greater by other radiographic technique

    • Lesions must be measurable in at least one dimension

    • Bone lesions, ascites, and effusions are not measurable

    • 18 years of age or older

    • ECOG performance status 0 or 1

    • Life expectancy of at least 12 weeks

    • Adequate bone marrow function

    • Adequate renal function

    • Adequate liver function

    Exclusion Criteria:
    • Prior chemotherapy (except as part of pre- or post-operative therapy, completed more than 1 year prior to start day of this protocol)

    • History of severe hypersensitivity to bevacizumab, docetaxel, cisplatin, irinotecan, or drugs formulated with polysorbate 80

    • Current, recent (within 4 weeks) or planned participation in an experimental drug study

    • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study

    • Minor surgical procedures, such as fine needle aspirations, port-a-cath placement, or core biopsies within 7 days prior to Day 0 of study

    • Myocardial infarction or stroke in past 6 months

    • Blood pressure of > 150/100 mmHg

    • Unstable angina

    • New York Heart Association (NYHA) grade II or greater congestive heart failure

    • Clinically significant peripheral vascular disease

    • Persistent bleeding from primary tumor, while off anticoagulants, requiring repeated transfusions

    • Evidence of bleeding diathesis or coagulopathy

    • Uncontrolled serious medical or psychiatric illness

    • Uncontrolled diarrhea

    • Peripheral neuropathy > grade 1

    • Clinically apparent central nervous system metastases or carcinomatous meningitis

    • Other active malignancy other than non-melanoma skin cancer or in situ cervical carcinoma.

    • Urine protein: creatinine ratio of 1.0 or greater at screening

    • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1

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

    • Pregnant or breast-feeding

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114
    2 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02115
    3 Dana-Farber Cancer Institute Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Dana-Farber Cancer Institute
    • Brigham and Women's Hospital
    • Massachusetts General Hospital
    • Genentech, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peter C. Enzinger, MD, Overall PI, Dana-Farber Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT00394433
    Other Study ID Numbers:
    • 06-100
    First Posted:
    Nov 1, 2006
    Last Update Posted:
    Aug 1, 2017
    Last Verified:
    Jul 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Peter C. Enzinger, MD, Overall PI, Dana-Farber Cancer Institute
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Patients (n=38) were enrolled between September 2006 and March 2008.
    Pre-assignment Detail
    Arm/Group Title Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)
    Arm/Group Description Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
    Period Title: Overall Study
    STARTED 38
    Evaluable and Treated 35
    COMPLETED 35
    NOT COMPLETED 3

    Baseline Characteristics

    Arm/Group Title Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)
    Arm/Group Description Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
    Overall Participants 38
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    58
    Sex: Female, Male (Count of Participants)
    Female
    6
    15.8%
    Male
    32
    84.2%
    Race/Ethnicity, Customized (Count of Participants)
    White
    33
    86.8%
    Black or African American
    2
    5.3%
    Hispanic
    3
    7.9%
    Region of Enrollment (Count of Participants)
    United States
    38
    100%
    Primary Site of Disease (Count of Participants)
    Esophageal
    13
    34.2%
    Gastroesophageal junction
    9
    23.7%
    Gastric
    16
    42.1%

    Outcome Measures

    1. Primary Outcome
    Title 10-month Progression-Free Survival Rate
    Description 10-month progression-free survival rate is the probability of patients remaining alive and progression-free at 10-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; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 10 months.

    Outcome Measure Data

    Analysis Population Description
    The analysis dataset is comprised of all enrolled patients.
    Arm/Group Title Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)
    Arm/Group Description Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
    Measure Participants 38
    Number (95% Confidence Interval) [probability (%)]
    40.0
    2. 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 continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).

    Outcome Measure Data

    Analysis Population Description
    The analysis dataset is comprised of all treated and evaluable patients.
    Arm/Group Title Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)
    Arm/Group Description Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
    Measure Participants 35
    Partial Response
    23
    60.5%
    Stable Disease
    7
    18.4%
    Progressive Disease
    5
    13.2%
    3. 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 for a median of 12.2 month (up to 40 months).

    Outcome Measure Data

    Analysis Population Description
    The analysis dataset is comprised of all enrolled patients.
    Arm/Group Title Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)
    Arm/Group Description Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
    Measure Participants 38
    Median (95% Confidence Interval) [months]
    14.9
    4. 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. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).

    Outcome Measure Data

    Analysis Population Description
    The analysis dataset is comprised of all enrolled patients.
    Arm/Group Title Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)
    Arm/Group Description Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
    Measure Participants 38
    Median (95% Confidence Interval) [months]
    8.9

    Adverse Events

    Time Frame Adverse events were assessed weeks 1 and 2 each cycle throughout treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).
    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. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term.
    Arm/Group Title Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)
    Arm/Group Description Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
    All Cause Mortality
    Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)
    Affected / at Risk (%) # Events
    Total 30/38 (78.9%)
    Blood and lymphatic system disorders
    Hemoglobin 2/38 (5.3%)
    Febrile neutropenia 6/38 (15.8%)
    Gastrointestinal disorders
    Constipation 1/38 (2.6%)
    Diarrhea w/o prior colostomy 16/38 (42.1%)
    Dysphagia 1/38 (2.6%)
    Esophagitis 2/38 (5.3%)
    Ileus 1/38 (2.6%)
    Nausea 4/38 (10.5%)
    Vomiting 2/38 (5.3%)
    Upper GI, hemorrhage NOS 2/38 (5.3%)
    Abdomen, pain 2/38 (5.3%)
    General disorders
    Fatigue 7/38 (18.4%)
    Immune system disorders
    Allergic reaction 1/38 (2.6%)
    Infections and infestations
    Infection w/ gr3-4 neut, vulva 1/38 (2.6%)
    Infection Gr0-2 neut, lung 1/38 (2.6%)
    Infection Gr 0-2 neut, blood 1/38 (2.6%)
    Investigations
    Leukocytes 9/38 (23.7%)
    Lymphopenia 12/38 (31.6%)
    Neutrophils 12/38 (31.6%)
    Weight gain 1/38 (2.6%)
    INR 1/38 (2.6%)
    ALT, SGPT 1/38 (2.6%)
    Metabolism and nutrition disorders
    Anorexia 6/38 (15.8%)
    Dehydration 5/38 (13.2%)
    Hypoalbuminemia 1/38 (2.6%)
    Hypocalcemia 3/38 (7.9%)
    Hyperglycemia 1/38 (2.6%)
    Hypomagnesemia 2/38 (5.3%)
    Hypophosphatemia 2/38 (5.3%)
    Hypokalemia 6/38 (15.8%)
    Hyponatremia 4/38 (10.5%)
    Nervous system disorders
    Neuropathy-motor 1/38 (2.6%)
    Syncope 1/38 (2.6%)
    Respiratory, thoracic and mediastinal disorders
    Hiccoughs 1/38 (2.6%)
    Nasal cavity/paranasal sinus reaction 1/38 (2.6%)
    Pulmonary/Upper Respiratory-other 1/38 (2.6%)
    Vascular disorders
    Hypertension 2/38 (5.3%)
    Hypotension 1/38 (2.6%)
    Thrombosis/thrombus/embolism 6/38 (15.8%)
    Other (Not Including Serious) Adverse Events
    Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)
    Affected / at Risk (%) # Events
    Total 37/38 (97.4%)
    Blood and lymphatic system disorders
    Hemoglobin 28/38 (73.7%)
    Hematologic 5/38 (13.2%)
    Lymphatics 1/38 (2.6%)
    Ear and labyrinth disorders
    Hearing 1/38 (2.6%)
    External ear, pain 1/38 (2.6%)
    Eye disorders
    Vision-blurred 1/38 (2.6%)
    Tearing 3/38 (7.9%)
    Ocular 1/38 (2.6%)
    Gastrointestinal disorders
    Ascites (non-malignant) 1/38 (2.6%)
    Constipation 22/38 (57.9%)
    Diarrhea w/o prior colostomy 19/38 (50%)
    Distention/bloating, abdominal 3/38 (7.9%)
    Dry mouth 1/38 (2.6%)
    Dysphagia 4/38 (10.5%)
    Flatulence 7/38 (18.4%)
    Dyspepsia 7/38 (18.4%)
    Hemorrhoids 1/38 (2.6%)
    Muco/stomatitis by exam, oral cavity 7/38 (18.4%)
    Muco/stomatitis (symptom) oral cavity 3/38 (7.9%)
    Nausea 30/38 (78.9%)
    Ulcer, rectum 1/38 (2.6%)
    Vomiting 24/38 (63.2%)
    GI-other 8/38 (21.1%)
    Rectum, hemorrhage 1/38 (2.6%)
    Abdomen, pain 18/38 (47.4%)
    Esophagus, pain 1/38 (2.6%)
    Oral cavity, pain 2/38 (5.3%)
    Rectum, pain 1/38 (2.6%)
    Stomach, pain 7/38 (18.4%)
    General disorders
    Fatigue 28/38 (73.7%)
    Fever w/o neutropenia 6/38 (15.8%)
    Rigors/chills 4/38 (10.5%)
    Constitutional 1/38 (2.6%)
    Injection site reaction 1/38 (2.6%)
    Edema limb 5/38 (13.2%)
    Chest/thoracic pain NOS 5/38 (13.2%)
    Pain NOS 3/38 (7.9%)
    Pain-other 3/38 (7.9%)
    Hepatobiliary disorders
    Liver, pain 1/38 (2.6%)
    Immune system disorders
    Allergic reaction 2/38 (5.3%)
    Allergy-other 1/38 (2.6%)
    Infections and infestations
    Infection w/ gr3-4 neut, skin 1/38 (2.6%)
    Infection Gr0-2 neut, lung 1/38 (2.6%)
    Infection-other 2/38 (5.3%)
    Injury, poisoning and procedural complications
    Wound - non-infectious 2/38 (5.3%)
    Investigations
    Leukocytes 20/38 (52.6%)
    Lymphopenia 7/38 (18.4%)
    Neutrophils 11/38 (28.9%)
    Platelets 8/38 (21.1%)
    Weight gain 1/38 (2.6%)
    Weight loss 7/38 (18.4%)
    Alkaline phosphatase 7/38 (18.4%)
    ALT, SGPT 8/38 (21.1%)
    AST, SGOT 8/38 (21.1%)
    Bilirubin 2/38 (5.3%)
    Creatinine 6/38 (15.8%)
    Metabolism and nutrition disorders
    Anorexia 18/38 (47.4%)
    Dehydration 15/38 (39.5%)
    Hypoalbuminemia 13/38 (34.2%)
    Bicarbonate 8/38 (21.1%)
    Hypocalcemia 15/38 (39.5%)
    Hyperglycemia 13/38 (34.2%)
    Hypoglycemia 2/38 (5.3%)
    Hypomagnesemia 10/38 (26.3%)
    Hypophosphatemia 3/38 (7.9%)
    Hyperkalemia 10/38 (26.3%)
    Hypokalemia 6/38 (15.8%)
    Hypernatremia 2/38 (5.3%)
    Hyponatremia 17/38 (44.7%)
    Musculoskeletal and connective tissue disorders
    Arthritis 1/38 (2.6%)
    Nonneuropathic lower extr muscle weak 1/38 (2.6%)
    Nonneuropathic generalized weakness 7/38 (18.4%)
    Back, pain 2/38 (5.3%)
    Chest wall, pain 1/38 (2.6%)
    Extremity-limb, pain 1/38 (2.6%)
    Joint, pain 3/38 (7.9%)
    Muscle, pain 2/38 (5.3%)
    Nervous system disorders
    Taste disturbance 13/38 (34.2%)
    Dizziness 15/38 (39.5%)
    Neuropathy-motor 2/38 (5.3%)
    Neuropathy-sensory 11/38 (28.9%)
    Head/headache 10/38 (26.3%)
    Psychiatric disorders
    Insomnia 7/38 (18.4%)
    Anxiety 3/38 (7.9%)
    Depression 3/38 (7.9%)
    Libido 1/38 (2.6%)
    Renal and urinary disorders
    Glomerular filtration rate 1/38 (2.6%)
    Proteinuria 1/38 (2.6%)
    Urinary frequency/urgency 1/38 (2.6%)
    Reproductive system and breast disorders
    Pelvic, pain 1/38 (2.6%)
    Erectile impotence 1/38 (2.6%)
    Respiratory, thoracic and mediastinal disorders
    Allergic rhinitis 11/38 (28.9%)
    Muco/stomatitis (symptom) trachea 1/38 (2.6%)
    Nose, hemorrhage 13/38 (34.2%)
    Throat/pharynx/larynx, pain 3/38 (7.9%)
    Cough 7/38 (18.4%)
    Dyspnea 7/38 (18.4%)
    Hiccoughs 1/38 (2.6%)
    Nasal cavity/paranasal sinus reaction 3/38 (7.9%)
    Pleural effusion (non-malignant) 1/38 (2.6%)
    Voice changes/dysarthria 12/38 (31.6%)
    Pulmonary/Upper Respiratory 1/38 (2.6%)
    Skin and subcutaneous tissue disorders
    Erythema multiforme 3/38 (7.9%)
    Sweating 1/38 (2.6%)
    Dry skin 2/38 (5.3%)
    Alopecia 19/38 (50%)
    Nail changes 4/38 (10.5%)
    Pruritus/itching 1/38 (2.6%)
    Rash/desquamation 2/38 (5.3%)
    Rash: acne/acneiform 1/38 (2.6%)
    Hand-foot reaction 2/38 (5.3%)
    Ulceration 1/38 (2.6%)
    Skin 5/38 (13.2%)
    Petechiae 1/38 (2.6%)
    Scalp, pain 1/38 (2.6%)
    Vascular disorders
    Hemorrhage 1/38 (2.6%)
    Hypertension 6/38 (15.8%)
    Hypotension 1/38 (2.6%)
    Hot flashes 3/38 (7.9%)
    Hemorrhage 3/38 (7.9%)

    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 C. Enzinger, MD
    Organization Dana-Farber Cancer Institute
    Phone 617-632-6855
    Email Peter_Enzinger@dfci.harvard.edu
    Responsible Party:
    Peter C. Enzinger, MD, Overall PI, Dana-Farber Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT00394433
    Other Study ID Numbers:
    • 06-100
    First Posted:
    Nov 1, 2006
    Last Update Posted:
    Aug 1, 2017
    Last Verified:
    Jul 1, 2017