Melanoma Clinical Trial
Official title:
Phase 2 Study of the Combination of BAY 43-9006 (Sorafenib) and CCI-779 (Temsirolimus) in Patients With Metastatic Melanoma
This phase II portion of the trial is studying the side effects and best dose of temsirolimus when given together with sorafenib and to see how well they work in treating patients with metastatic, recurrent, or unresectable melanoma. Sorafenib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with temsirolimus may kill more tumor cells.
PRIMARY OBJECTIVES:
- To evaluate the clinical activity, in terms of overall response rate (complete and
partial response), of this regimen in these patients. (Phase II)
- To evaluate the in vivo biological activity of this regimen in these patients.
SECONDARY OBJECTIVES:
I. To determine the progression-free survival and overall survival of patients treated with
this regimen.
II. To determine the safety and toxicity of this regimen in these patients.
III. To Determine the population pharmacokinetics of this regimen in these patients.
IV. To correlate tumor and blood biomarkers with clinical outcome in patients treated with
this regimen.
OUTLINE: Upon completion of the multicenter, phase I, dose-escalation study followed to be
followed by this phase II, open-label study.
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22 and oral sorafenib
once or twice daily on days 1-28. Treatment course repeats every 28 days for up to 6 courses
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3-6 months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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