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Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Biliary Tract and Gallbladder Cancer

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ClinicalTrials.gov Identifier: NCT00361231
Recruitment Status : Completed
First Posted : August 8, 2006
Results First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Collaborators:
Genentech, Inc.
Sanofi
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Andrew X. Zhu, MD, Massachusetts General Hospital

Study Description
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Brief Summary:
The purposes of this study are to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good and bad) this combination has on patients with cancer of bile duct or gallbladder. Bevacizumab has been shown to slow or stop cell growth in tumors by decreasing the blood supply to the tumors.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Gallbladder Adenocarcinoma Drug: Bevacizumab Drug: Gemcitabine Drug: Oxaliplatin Phase 2

Detailed Description:
  • The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
  • Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
  • The following tests and procedures will be performed on day 1 and day 15 or each cycle: physical examination; medical history; blood work; and urine test. A PET scan will be repeated at the end of cycle 2 and CT scans will be repeated once every 8 weeks.
  • Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Unresectable or Metastatic Biliary Tract and Gallbladder Cancer
Study Start Date : May 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Bevacizumab, Gemcitabine, Oxaliplatin
  • The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
  • Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
  • Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
 Drug: Bevacizumab
Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Other Name: Avastin

Drug: Gemcitabine
Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Other Name: Gemzar

Drug: Oxaliplatin
Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Other Name: Eloxatin


Outcome Measures
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Primary Outcome Measures :
  1. Median Progression Free Survival [ Time Frame: 2 years ]
    To assess the median progression free survival in patients with BTC on GEMOX-B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition, death in the absence of radiological disease progression was also categorized as progression.


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 2 years ]
    To assess the overall response rate of GEMOX-B in patients with advanced BTC. Response rate is determined through Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed, locally unresectable or metastatic biliary tract or gallbladder adenocarcinoma. Patients must have at least one measurable lesion outside prior radiation field.
  • Zero to one prior chemotherapy for biliary tract or gallbladder cancer
  • Age > 18 years
  • ECOG performance status 0-2
  • Life expectancy > 12 weeks
  • Adequate organ and bone marrow function

Exclusion Criteria:

  • Chemotherapy within past 3 weeks of initiation of therapy
  • Pregnant or lactating women
  • Clinically apparent central nervous system metastases or carcinomatous meningitis
  • Biliary obstruction with inadequate drainage and total bilirubin > 2.5 mg/dL
  • Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • Uncontrolled serious medical or psychiatric illness
  • Pre-existing peripheral neuropathy of grade 2 or greater severity according to the Common Terminology Criteria of the NCI (version 3.0)
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
  • Blood pressure of > 150/100 mmHg
  • Unstable angina
  • NYHA Grade II or greater congestive heart failure
  • History of myocardial infarction or stroke within 6 months
  • Clinically significant peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Major surgical procedure, open biopsy, or significant traumatic injury with 28 days prior to Day 1, anticipation of need for major surgical procedure during the course of the study
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00361231


Locations
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United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Massachusetts General Hospital
Genentech, Inc.
Sanofi
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Andrew X. Zhu, MD Massachusetts General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Andrew X. Zhu, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00361231    
Other Study ID Numbers: 05-349
First Posted: August 8, 2006    Key Record Dates
Results First Posted: February 7, 2017
Last Update Posted: February 7, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Andrew X. Zhu, MD, Massachusetts General Hospital:
Avastin
GEMOX
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Gallbladder Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Gemcitabine
Bevacizumab
Oxaliplatin
Antineoplastic Agents, Immunological
Antineoplastic Agents
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors