Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Patients With Biliary Tract and Gallbladder Cancer

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Dana-Farber Cancer Institute; Genentech, Inc.; Hoffmann-La Roche; Sanofi-Synthelabo
• Treatments: Bevacizumab; Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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