Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II study of biweekly (every other week) bevacizumab followed by gemcitabine then infusional 5-fluorouracil in patients with stage III or IV pancreatic cancer. Patients' response will be evaluated every 8 weeks using usual CT scanning techniques. RECIST (Response Evaluation Criteria in Solid tumors) criteria will be applied to evaluate response. Tumor marker levels (Ca 19-9) will be assessed every 4 weeks, but will not be used to measure response.

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

Details

• Lead Sponsor: Tony Bekaii-Saab
• Collaborator: Genentech, Inc.
• Treatments: Bevacizumab; Fluorouracil; Gemcitabine; Pancrelipase

Criteria

Inclusion Criteria:

• Males or females age >=18 years.

• Established histological confirmation of adenocarcinoma of the pancreas.

• Stage III and stage IV will be allowed.

Exclusion Criteria:

• No prior chemotherapy or radiotherapy allowed except for that given as part of an adjuvant regimen if >4 weeks have elapsed since the end of therapy. Any prior treatment with antibodies to VEGF.

• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting the study.

• Pregnant or lactating women.