Status:
COMPLETED
Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Patients With Biliary Tract and Gallbladder Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Conditions:
Biliary Tract Cancer
Gallbladder Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
There are two phases of study treatment. The first phase is for all patients and will last about 6 weeks. During this phase, oxaliplatin will be given intravenously once a week during weeks 1, 2, 4, a...
Eligibility Criteria
Inclusion
- Histologically confirmed locally advanced unresectable biliary tract or gallbladder adenocarcinoma
- Patients with resected biliary tract or gallbladder adenocarcinoma who have residual tumor left will also be eligible.
- \> 4 weeks since time of major surgery
- \> 2 weeks since time of minor surgery
- \> 4 weeks since time of major radiotherapy for other malignancy
- \> 4 weeks since participation in any investigational drug study
- \> 1 year since treatment for other carcinomas, except cured non-melanoma skin and treated in-situ cervical cancer
- 18 years of age or older
- ECOG performance status of 0-2
- Life expectancy \> 12 weeks
- Absolute neutrophil count (ANC) \> 1,500/mm3
- Hemoglobin \> 9.0 gm/dl
- Platelets \> 100,000/mm3
- SGOT \< 5 x upper limits of normal (ULN)
- Total bilirubin \< 2.5 mg/dl
- Creatinine clearance \> 50 ml/min
Exclusion
- Prior chemotherapy or radiation therapy for biliary tract or gallbladder cancer
- Peripheral neuropathy of grade 2 or greater
- Unstable angina
- Symptomatic congestive heart failure
- Myocardial infarction \< 12 months prior to registration
- New York Heart Association classification III or IV
- Active or uncontrolled infection
- Known existing uncontrolled coagulopathy
- Malabsorption syndrome or lack of integrity of the upper gastrointestinal (GI) tract
- Prior unanticipated severe reaction to fluoropyrimidine therapy or known sensitivity to 5-fluorouracil, or known dihydropyrimidine dehydrogenase (DPD) deficiency
- Known brain metastases or carcinomatous meningitis
- Pregnant or lactating women
- Serious, non-healing wound, ulcer, or bone fracture
- Evidence of bleeding diathesis or coagulopathy
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00142480
Start Date
December 1 2004
End Date
April 1 2011
Last Update
April 25 2018
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02118