Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-31 @ 2:01 PM
Study NCT ID:
NCT00919035
Status:
COMPLETED
Last Update Posted:
2014-06-30
First Post:
2009-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Single Agent Temsirolimus (Torisel®) in Chemotherapy-naïve Castration-Resistant Prostate Cancer Patients
Sponsor:
Oncology Specialists, S.C.
Organization:
Study Overview
Official Title:
Phase II Study Investigating the Toxicity and Efficacy of Single Agent Temsirolimus (Torisel®) in Chemotherapy-naïve Castration-Resistant Prostate Cancer Patients
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: