Sorafenib and Temsirolimus in Treating Patients With Metastatic, Recurrent, or Unresectable Melanoma
Stage III Melanoma
Stage IV Melanoma
Drug: sorafenib tosylate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 Study of the Combination of BAY 43-9006 (Sorafenib) and CCI-779 (Temsirolimus) in Patients With Metastatic Melanoma|
- Objective response rate (complete response and partial response) CCI-779 in combination with BAY43-9006 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: The duration of time from start of treatment to date of first evidence of progression or the date of last follow-up for patients who do not progress, assessed up to 5 years ] [ Designated as safety issue: No ]Kaplan-Meier life table methods and Cox proportional hazards regression modeling will be utilized to analyze progression-free survival and overall survival.
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]Kaplan-Meier life table methods and Cox proportional hazards regression modeling will be utilized to analyze progression-free survival and overall survival.
- Noncompartmental pharmacokinetic parameters of BAY43-9006 and CCI-779 estimated using a validated commercial software [ Time Frame: Week 1 and 3 ] [ Designated as safety issue: No ]Maximum concentration (Cmax) and time to Cmax (tmax) will be the observed values. Area under the plasma concentration-time curve from zero to last observable time (AUClast).
|Study Start Date:||April 2006|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: Temsirolimus + Sorafenib
Temsirolimus intravenous (IV) over 30 minutes on days 1, 8,15, and 22 and oral sorafenib once or twice daily on days 1-28.
Drug: sorafenib tosylate
Other Names:Drug: temsirolimus
- 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01851408
|Principal Investigator:||Kevin Kim||M.D. Anderson Cancer Center|