Status:
COMPLETED
Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Patients With Hepatocellular Carcinoma
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 c...
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 af...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00142467
Start Date
April 1 2004
End Date
June 1 2011
Last Update
March 18 2014
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115