Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Patients With Biliary Tract and Gallbladder Cancer
NCT00142480 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2018-04-25
Summary
The main purpose of this study is to test the safety and effectiveness of oxaliplatin, bevacizumab, and capecitabine given in combination with radiation therapy to see what effects (good or bad) they have on patients with biliary tract and gallbladder cancer.
Conditions
- Biliary Tract Cancer
- Gallbladder Adenocarcinoma
Interventions
- DRUG
-
Given orally for 14 consecutive days (days 1-14) followed by a week of no capecitabine then another week of 14 consecutive days (days 21-28).
- DRUG
-
Given intravenously once weekly during weeks 1, 2, 4 and 5 on days 1, 8, 22 and 29
- DRUG
-
Given intravenously every two weeks during weeks 1, 3 and 5 on days 1, 15 and 29.
- PROCEDURE
-
Radiation therapy
Once daily for 5 days (Monday through Friday) for a total of 28 treatments.
Sponsors & Collaborators
- collaborator OTHER
-
Beth Israel Deaconess Medical Center
collaborator OTHER -
Brigham and Women's Hospital
collaborator OTHER -
Genentech, Inc.
collaborator INDUSTRY -
Sanofi-Synthelabo
collaborator INDUSTRY - collaborator INDUSTRY
-
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Andrew Zhu, MD · Massachusetts General Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-12-31
- Primary Completion
- 2007-07-31
- Completion
- 2011-04-30
Countries
- United States
Study Locations
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