Liver Cancer Clinical Trial
Official title:
Sorafenib Alone or in Combination With Everolimus in Patients With Unresectable Hepatocellular Carcinoma. A Randomized Multicenter Phase II Trial.
RATIONALE: Sorafenib tosylate and everolimus may stop the growth of tumor cells by blocking
some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This randomized phase II trial is studying giving sorafenib tosylate together with
everolimus to see how well it works compared with sorafenib tosylate alone in treating
patients with localized, unresectable, or metastatic liver cancer.
OBJECTIVES:
- To determine if sorafenib tosylate with versus without everolimus can stop tumor
progression in patients with localized, unresectable, or metastatic hepatocellular
carcinoma.
- To evaluate changes in symptom-related and global quality of life (QL) and QL benefit
over the course of trial treatment in these patients.
- To compare the primary endpoint (i.e., progression-free survival at week 12) to the QL
benefit within 12 weeks from baseline.
- To evaluate how symptom-related and global QL indicators map on the single summary index
derived from a standardized measure of health status for utility cost analysis.
OUTLINE: This is a multicenter study. Patients are stratified according to WHO performance
status (0 vs 1), disease spread (extrahepatic spread vs non-extrahepatic spread), and center.
Patients are randomized to 1 of 2 treatment arms.
- Arm A (standard treatment): Patients receive oral sorafenib tosylate twice daily for 4
weeks. Courses repeat every 4 weeks in the absence of disease progression or
unacceptable toxicity.
- Arm B (investigational treatment): Patients receive oral sorafenib tosylate twice daily
and oral everolimus once daily for 4 weeks. Courses repeat every 4 weeks in the absence
of disease progression or unacceptable toxicity.
Some patients may undergo CT scan or MRI at baseline and at 6 and 12 weeks during study to
assess tumor response, tumor size, and tumor density.
Patients complete quality of life questionnaires at baseline and every 2 weeks for 12 weeks
during study treatment.
After completion of study treatment, patients are followed every 2 months for 3 years.
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