Phase II Study Investigating the Toxicity and Efficacy of Single Agent Temsirolimus (Torisel®) in Chemotherapy-naïve Castration-Resistant Prostate Cancer Patients
This is an open label phase II study conducted in patients who have androgen-independent and
castration-resistant prostate cancer but who have not received systemic chemotherapy.
Investigational therapy such as vaccines, immunotherapy, and some oral targeted agents are
NOT considered chemotherapy. Prior use of steroids is not an exclusion criterion.
Patients who meet the inclusion criteria will be allowed to participate. Enrolled patients
will receive single agent Torisel® at 25 mg weekly. Every 4 weeks of therapy will
constitute one cycle of treatment. Patients will continue on therapy until voluntary
withdrawal, toxicity, progression, or the investigator's discretion. Patients will be
followed for 3 years after discontinuation of Torisel®.
Patients are allowed to receive intravenous or oral bisphosphonates for their bone
metastases and are advised to continue androgen blockade while on study.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the overall clinical benefit with Torisel® in chemotherapy-naïve CRPC. The overall clinical benefit is defined as the sum of complete response, partial response, and stable disease
disease progression is assessed every 2 cycles
No
Chadi Nabhan, MD
Principal Investigator
Oncology Specialists, S.C.
United States: Institutional Review Board
OSRI 0901
NCT00919035
June 2009
December 2013
Name | Location |
---|---|
Oncology Specialists, SC | Park Ridge, Illinois 60068 |
Oncology Specialists, S.C. | Park Ridge, Illinois 60068 |