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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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 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.

• 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.; Sanofi
• Treatments: Bevacizumab; Gemcitabine; Oxaliplatin

Criteria

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