Hepatocellular Carcinoma
Conditions
Keywords
Unresectable hepatocellular carcinoma, Metastatic hepatocellular carcinoma, gemcitabine, oxaliplatin, bevacizumab, Avastin
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.
Interventions
DRUGGemcitabine
DRUGOxaliplatin
DRUGBevacizumab
Sponsors
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Genentech, Inc.
Sanofi-Synthelabo
Eli Lilly and Company
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | 2 years | — |
| Objective response rate | 2 years | — |
| Overall survival | 2 years | From date of randomization until the date of death from any cause, assessed up to 2 years |
Countries
United States
Outcome results
None listed