NCT01005199

Sorafenib Tosylate With or Without Everolimus in Treating Patients With Localized, Unresectable, or Metastatic Liver Cancer

Sorafenib Alone or in Combination With Everolimus in Patients With Unresectable Hepatocellular Carcinoma. A Randomized Multicenter Phase II Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
DRUG	everolimus	Sorafenib 2 x 400 mg daily plus everolimus 1 x 5 mg daily
DRUG	sorafenib tosylate	Sorafenib 2 x 400 mg daily

Timeline

• Start date: 2009-11-01
• Primary completion: 2013-06-01
• Completion: 2016-03-01
• First posted: 2009-10-30
• Last updated: 2019-05-15

Locations

15 sites across 3 countries: Austria, Hungary, Switzerland