Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Patients With Hepatocellular Carcinoma
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT00142467
- Lead Sponsor
- Massachusetts General Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bevacizumab, Gemcitabine, Oxaliplatin Gemcitabine 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. Bevacizumab, Gemcitabine, Oxaliplatin 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. Bevacizumab, Gemcitabine, Oxaliplatin Bevacizumab 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.
- Primary Outcome Measures
Name Time Method Time to disease progression of gemcitabine, oxaliplatin and bevacizumab regimen in patients with hepatocellular carcinoma. 2 years From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
- Secondary Outcome Measures
Name Time Method Objective response rate 2 years Number of participants with adverse events 2 years Overall survival 2 years From date of randomization until the date of death from any cause, assessed up to 2 years
Trial Locations
- Locations (3)
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States