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

NCT ID: NCT00142467

Last Updated: 2014-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2011-06-30

Brief 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.

Detailed Description

• Treatment is given in cycles, each cycle (except for cycle 1) is 4 weeks long. Cycle 1 is only 2 weeks long.
• During cycle one only, bevacizumab will be given intravenously on day one. Two weeks after receiving bevacizumab, the patient will return to the clinic for treatment with all 3 study drugs.
• During cycle 2 and every cycle thereafter patients will receive; bevacizumab intravenously on day one and day 15; gemcitabine intravenously on day 2 and day 16; oxaliplatin intravenously on day 2 and day 16.
• The following evaluations will be conducted on day 1 and day 15 of each cycle (once every 2 weeks): physical examination, vital signs, medical history, blood tests and urine tests.
• Tumor measurements done by CT and/or MRI will be repeated at the end of cycle 3 and every 2 cycles thereafter.
• Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) of the liver and Perfusions CT scans will also be done on days 10-12 following bevacizumab treatment during cycle 1, and the Perfusion CT will be repeated at the end of cycle 3.
• Once study treatment is stopped the following evaluations will be performed: physical exam, vital signs, blood work, urine tests, CT scan of chest, abdomen and pelvis, and tumor measurements by CT or MRI scans.
• Follow-up will consist of physical examinations and blood tests every 6 months.
• Patients will continue to receive study treatment as long as there is no disease progression or unacceptable side affects.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab, Gemcitabine, Oxaliplatin

For cycle 1 (14 days), bevacizumab 10 mg/kg was administered alone on day 1. For cycle 2 and beyond (28 days/cycle), bevacizumab 10 mg/kg was administered on days 1 and 15, gemcitabine 1,000 mg/m2 was administered as a dose rate infusion at 10 mg/m2/min followed by oxaliplatin at 85 mg/m2 on days 2 and 16. All drugs were administered intravenously until progression, intolerance, patient withdrawal, or death.

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

Bevacizumab

Intervention Type: DRUG

Interventions

Gemcitabine

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

Bevacizumab

Intervention Type: DRUG

Other Intervention Names

Gemzar; Eloxatin; Avastin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Sanofi-Synthelabo

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Andrew X. Zhu, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

03-390

Identifier Type: -

Identifier Source: org_study_id