Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Patients With Hepatocellular Carcinoma
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Massachusetts General Hospital
- Study ID
- NCT00142467
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Gemcitabine — DRUG
- Oxaliplatin — DRUG
- Bevacizumab — DRUG
Study Details
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.
Key Dates
- First listed
- Sep 2, 2005
- Start date
- Apr 30, 2004
- Status verified
- Mar 2014
- Primary completion
- Aug 31, 2006
- Completion
- Jun 30, 2011
Study Design
- Enrollment
- 33 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Bevacizumab, Gemcitabine, OxaliplatinFor 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.
Primary Outcome Measure
Time to disease progression of gemcitabine, oxaliplatin and bevacizumab regimen in patients with hepatocellular carcinoma. [ Time Frame: 2 years ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | - |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | - |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | - |
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