Status:
COMPLETED
Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Biliary Tract and Gallbladder Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Genentech, Inc.
Sanofi
Conditions:
Biliary Tract Cancer
Gallbladder Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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. Gemcitabi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00361231
Start Date
May 1 2006
End Date
August 1 2012
Last Update
February 7 2017
Active Locations (2)
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1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02115
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215