Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Patients With Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good or bad) it has on patients with hepatocellular carcinoma.

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

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Dana-Farber Cancer Institute; Eli Lilly and Company; Genentech, Inc.; Sanofi-Synthelabo
• Treatments: Bevacizumab; Gemcitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• Unresectable or metastatic hepatocellular carcinoma

• Measurable tumors

• Adequate hepatic function: total bilirubin < 3.0mg/dl; AST < 7x ULN

• Adequate bone marrow function: ANC > 1,000/mm3; platelets > 75,000/mm3

• INR < 1.5 for those who are not on anticoagulation

• Up to two prior chemotherapy regimens for hepatocellular carcinoma

• 18 years of age or older

• ECOG performance status of 0-1

• Life expectancy of > 12 weeks

Exclusion Criteria:

• Clinically apparent central nervous system metastases or carcinomatous meningitis

• Uncontrolled serious medical or psychiatric illness

• Pregnant or lactating women

• Current or recent (within 4 weeks of first study infusion) participation in experimental study drug

• Uncontrolled hypertension

• Significant proteinuria

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

• Evidence of bleeding diathesis or coagulopathy