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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00361231
First received: August 4, 2006
Last updated: March 15, 2014
Last verified: March 2014

August 4, 2006
March 15, 2014
May 2006
March 2009   (final data collection date for primary outcome measure)
Median progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To assess the median progression free survival in patients with BTC on GEMOX-B.
To assess the progression free survival of GEMOX-B regimen in patients with unresectable or metastatic biliary tract and gallbladder adenocarcinoma.
Complete list of historical versions of study NCT00361231 on ClinicalTrials.gov Archive Site
  • Number of patients experiencing Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To evaluate the tolerability and toxicities of GEMOX-B in this population of patients.
  • Overall response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To assess the overall response rate of GEMOX-B in patients with advanced BTC.
  • Changes in SUVmax for RECIST response, progression free survival, and overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To assess changes in SUVmax from PET scans for RECIST response, progression free survival, and overall survival in patients receiving GEMOX-B for advanced BTC.
  • To evaluate the toxicities of the GEMOX-B regimen in this population of patients
  • to assess the response rate, the duration of response and median survival of GEMOX-B in this patient population
  • to evaluate changes on PET scans with treatment and correlation of PET scan change with PFS, response and OS.
Not Provided
Not Provided
 
Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Biliary Tract and Gallbladder Cancer
Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Unresectable or Metastatic Biliary Tract and Gallbladder Cancer

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.

  • 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.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Biliary Tract Cancer
  • Gallbladder Adenocarcinoma
  • 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.
  • 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.
  • 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.
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.
Interventions:
  • Drug: Bevacizumab
  • Drug: Gemcitabine
  • Drug: Oxaliplatin
Zhu AX, Meyerhardt JA, Blaszkowsky LS, Kambadakone AR, Muzikansky A, Zheng H, Clark JW, Abrams TA, Chan JA, Enzinger PC, Bhargava P, Kwak EL, Allen JN, Jain SR, Stuart K, Horgan K, Sheehan S, Fuchs CS, Ryan DP, Sahani DV. Efficacy and safety of gemcitabine, oxaliplatin, and bevacizumab in advanced biliary-tract cancers and correlation of changes in 18-fluorodeoxyglucose PET with clinical outcome: a phase 2 study. Lancet Oncol. 2010 Jan;11(1):48-54. Epub 2009 Nov 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
August 2012
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00361231
05-349
Yes
Andrew X. Zhu, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • Genentech, Inc.
  • Sanofi
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
Principal Investigator: Andrew X. Zhu, MD Massachusetts General Hospital
Massachusetts General Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP