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

Completed · Phase 2

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT00417976

Run by

Tony Bekaii-Saab

People needed

42

Starts

2006-12-01

Expected to finish

2011-02-01

Last updated by the study team

2015-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females age >=18 years.
• Established histological confirmation of adenocarcinoma of the pancreas.
• Stage III and stage IV will be allowed.

You may not qualify if…

• 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.

Where it is running

• The University of Michigan — Ann Arbor, Michigan, United States
• The Ohio State University James Cancer Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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