Randomized Phase II Trial Assessing the Combination of Nexavar® (Sorafenib), and Gemcitabine/Oxaliplatin in Patients Treated for Advanced (Unresectable/Metastatic) Hepatocellular Carcinoma.
- Assess progression-free survival (RECIST) in patients with locally advanced,
unresectable or metastatic hepatocellular carcinoma treated with sorafenib tosylate
with vs without gemcitabine hydrochloride and oxaliplatin.
- Evaluate the tolerability of these regimens in these patients.
- Determine the objective response rate (RECIST) in patients treated with these regimens.
- Assess the overall survival of patients treated with these regimens.
- Evaluate the pharmacokinetics of sorafenib tosylate.
- Assess biomarkers (e.g., pERK levels) associated with treatment response.
- Assess angiogenic response by functional imaging.
OUTLINE: This is a multicenter study. Patients are stratified according to performance
status and CLIP score. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral sorafenib tosylate as in arm I. Patients also receive
gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours
on day 2. Treatment with gemcitabine hydrochloride and oxaliplatin repeats every 14
days for 12 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral sorafenib tosylate twice daily on days 1-14. In both
arms, courses with sorafenib tosylate repeat every 14 days in the absence of disease
progression or unacceptable toxicity.
Blood samples and/ or tumor tissue samples may be collected for further analysis.
After completion of study therapy, patients are followed every 2 months until disease
progression and then every 6 months thereafter.
Allocation: Randomized, Primary Purpose: Treatment
Tumor response according to RECIST criteria
Eric Assenat, MD
Hopital Saint Eloi