Conditions: Renal Cell Carcinoma
Keywords: Metastatic or Advanced Renal Cell Carcinoma
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 512
Healthy volunteers: no

Brief summary:
This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Sorafenib intervention 2: temsirolimus (Torisel)
Intervention descriptions: intervention 1: Subjects randomized to arm B will take sorafenib 400 mg (2 x 200 mg tablets) PO, BID (total daily dose of 800 mg). intervention 2: Subjects randomized to arm A will receive temsirolimus (Torisel) 25 mg via IV infusion once weekly. This infusion is to be administered over a 30-60 minute period. Subjects are to be pre-treated with 25-50 mg IV diphenhydramine (or comparable IV antihistamine) approximately 30 minutes before temsirolimus infusion.

Protocol document: