Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to learn whether or not the combination of gemcitabine, bevacizumab and erlotinib works in treating patients with advanced or metastatic pancreatic cancer. Bevacizumab is a new anti-cancer drug. It is an antibody that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors. It is approved by the FDA for the treatment of colorectal cancer but is still considered investigational for treating pancreatic cancer.

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

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Dana-Farber Cancer Institute; Genentech, Inc.
• Treatments: Bevacizumab; Erlotinib Hydrochloride; Gemcitabine

Criteria

Inclusion Criteria:

• Previously untreated patients with unresectable or metastatic adenocarcinoma of the pancreas

• ECOG Performance Status 0-2

• 18 years of age or older

• Radiographically measurable disease

• Expected survival of at least 4 months

• Creatinine of
• Adequate hepatic function

• Adequate hematopoietic function

• Use of effective means of contraception in subjects of child-bearing potential

Exclusion Criteria:

• Warfarin anticoagulation

• Prior treatment with a tyrosine kinase inhibitor, EGFR inhibitor, or VEGF inhibitor

• Coexistent malignant disease

• Current or recent (within 4 weeks) participation in a clinical trial

• Pregnancy

• Documented invasion of adjacent organs or major blood vessels

• Blood pressure of > 150/100mmHg

• 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 of coagulopathy

• Presence of CNS or brain metastases

• Major surgical procedure, open biopsy, or significant traumatic event within 28 days

• Minor surgical procedures, fine needle aspirations or core biopsies within 7 days

• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months

• Serious non-healing wound, ulcer or bone fracture