Single Agent Temsirolimus (Torisel®) in Chemotherapy-naïve Castration-Resistant Prostate Cancer Patients
This is a single institution, open label, phase II study in androgen-independent prostate cancer patients who are chemotherapy-naïve. Patients will receive Torisel® 25 mg weekly. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study Investigating the Toxicity and Efficacy of Single Agent Temsirolimus (Torisel®) in Chemotherapy-naïve Castration-Resistant Prostate Cancer Patients|
- 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 [ Time Frame: disease progression is assessed every 2 cycles ] [ Designated as safety issue: No ]
- To evaluate the time to disease progression [ Time Frame: Proportion of patients alive at 1, 2 and 3 years ] [ Designated as safety issue: No ]
- To investigate the toxicity and tolerability using the NCI CTCAE criteria [ Time Frame: throughout the time the patient is on study ] [ Designated as safety issue: Yes ]
- To evaluate the time to systemic chemotherapy and time to alternative therapy [ Time Frame: actual day patient starts next treatment ] [ Designated as safety issue: No ]
- To assess the changes in PSA doubling time before and after treatment [ Time Frame: evaluate time frame using dates and actual PSA values ] [ Designated as safety issue: No ]
- Biochemical responses measured by serum PSA changes [ Time Frame: Using actual PSA values and dates from start of study - lasting through out study ] [ Designated as safety issue: No ]
- Proportion of patients alive at 1, 2, & 3 years [ Time Frame: use actual data ] [ Designated as safety issue: No ]
- Impact of treatment on quality of life (QOL) and pain scores using the MDASI & BPI published scales [ Time Frame: baseline, C3 & C5 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Single Agent Temsorilmus (Torisel®)
Patients will receive Torisel 25 mg weekly. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion
Other Name: Temsirolimus
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.
|United States, Illinois|
|Oncology Specialists, SC|
|Niles, Illinois, United States, 60714|
|Oncology Specialists, S.C.|
|Park Ridge, Illinois, United States, 60068|
|Principal Investigator:||Chadi Nabhan, MD||Oncology Specialists, S.C.|