Study of Bevacizumab in Combination With 5-FU, Oxaliplatin and External Beam Radiation Followed by Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer

• Status: Terminated
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is determine the safety of bevacizumab, oxaliplatin, 5-FU, and gemcitabine in combination with external beam radiation therapy(Phase I portion) as well as to begin to collect information about whether this combination treatment is effective in treating patients with locally advanced pancreatic cancer (Phase II portion).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Dana-Farber Cancer Institute; Genentech, Inc.; Sanofi
• Treatments: Angiogenesis Inhibitors; Bevacizumab; Fluorouracil; Gemcitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically and radiologically confirmed locally advanced pancreatic ductal adenocarcinoma and have not received prior therapy

• Disease is measurable by CT scan

• Age >= to 18 years

• Life expectancy of 4 months or longer

• ANC >/= 1,500mm/cm3

• Hemoglobin >/= 9g/dl

• Platelet count >/= 100,000/cm3

• Total bilirubin
• SGOT/SGPT
• Serum creatinine < 2mg/dl

• No evidence of metastatic disease by laparoscopy

Exclusion Criteria:

• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk for complications

• No secondary malignancies other than non-melanoma skin cancers or carcinoma in-situ of the cervix within past 5 years

• Patients with pre-existing peripheral neuropathy of grade 2 or greater

• Pregnant or lactating women

• Current, recent (within 4 weeks of study entry) or planned participation in an experimental drug study

• Blood pressure of >150/100 mmHg

• Unstable angina

• New York Heart Association 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

• Presence of central nervous system or brain metastases

• Major surgical procedure, open biopsy,m or significant traumatic injury within 28 days prior to day 0

• Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0

• Urine protein creatinine ratio > or = to 1.0 at screening

• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 0

• Serious, non-healing wound, ulcer, or bone fracture