Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor cells.

PURPOSE: This clinical trial is studying the side effects and how well giving gemcitabine and capecitabine together with bevacizumab works in treating patients with pancreatic cancer that can be removed by surgery.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bevacizumab; Capecitabine; Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed pancreatic adenocarcinoma

• Resectable disease (i.e., stage I or II disease)

• No unresectable (i.e., locally advanced) disease

• No tumor invasion into the stomach or duodenum

• No CNS, brain, or systemic metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• WBC > 3,000/μL

• ANC > 1,500/μL

• Platelet count > 100,000/μL

• Total bilirubin < 2 mg/dL

• AST or ALT < 2.5 times upper limit of normal (ULN)

• Creatinine < 1.5 mg/dL

• Creatinine clearance ≥ 50 mL/min

• Urine protein:creatinine ratio < 1.0

• Hemoglobin ≥ 9 g/dL (transfusion, epoetin alfa, or darbepoetin allowed)

• INR < 1.5 times ULN (except in patients receiving full-dose warfarin)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No uncontrolled hypertension

• No unstable angina

• No New York Heart Association class II-IV congestive heart failure

• No myocardial infarction or stroke within the past 6 months

• No clinically significant peripheral vascular disease

• No evidence of bleeding diathesis or coagulopathy

• No significant traumatic injury within the past 28 days

• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months

• No esophageal or gastric varices

• No serious nonhealing wound, ulcer, or bone fracture

PRIOR CONCURRENT THERAPY:

• No prior therapy for pancreatic cancer

• More than 4 weeks since prior and no concurrent participation in another experimental drug study

• More than 28 days since prior major surgical procedure or open biopsy

• More than 7 days since prior minor surgical procedure (e.g., fine-needle aspiration or core biopsy)