A Phase II Trial of TPI 287 in Patients With Metastatic Prostate Cancer
The primary objective of the study is to determine the response rate to TPI 287 in patients with metastatic, hormone-refractory prostate cancer who have had one prior taxane regimen.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of TPI 287 in Patients With Metastatic Prostate Cancer Who Have Progressive Neoplastic Disease Following Treatment With One Prior Taxane Regimen|
- Response [ Time Frame: 15 months ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: 15 months ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Safety [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2007|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
|Experimental: TPI 287||
Drug: TPI 287
160 mg/m2 every three weeks for six cyclesDrug: TPI 287
160 mg/m2 intravenously over 60 minutes every three weeks until toxicity or progression of disease.
This is an open-label, multi-center, 2-stage Simon design, Phase 2 study of TPI 287 in patients with metastatic, hormone-refractory prostate cancer. All patients must have received prior taxane therapy. Up to 80 patients will be enrolled and stratified based on duration of cumulative exposure to a single prior taxane regimen. A single taxane regimen is considered to he a taxane or taxane containing therapy administered on a defined schedule with no more than 2 months' interruption between treatments, and total exposure will be assessed by the number of months on that schedule.
One stratum (up to 40 patients) will consist of patients who have had over 3 months (up to a maximum of 10 months) exposure to a taxane regimen, who then have documented progression of disease (initially taxane sensitive). The second stratum (up to 40 patients) will consist of patients considered primarily resistant to taxanes who have had documented progressive disease as best response after exposure to a single taxane regimen for less than or equal to 3 months. Patients may have received prior hormonal therapy and/or bisphosphonates and may continue on these therapies.
In the first stage of the trial, 22 patients in each stratum will be treated with TPI 287 intravenously every 21 days. If 1 or fewer patients in either stratum demonstrate a response in this first stage, the trial will be discontinued for that stratum. Otherwise, an additional 18 patients in the stratum showing 2 or more responses will be enrolled in the second stage of the study. If 4 or fewer patients demonstrate a response in the total study population in either stratum from stages 1 and 2, then the drug will not be considered of interest in prostate cancer for patients as defined in that stratum.
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Comprehensive Cancer Center at Desert Mountain|
|Palm Springs, California, United States, 92262|
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|United States, Missouri|
|Kansas City Cancer Center South|
|Kansas City, Missouri, United States, 64131|
|United States, New Jersey|
|St. Barnabas Medical Center|
|Livingston, New Jersey, United States, 07039|
|United States, Tennessee|
|Tennessee Oncology, PLLC|
|Nashville, Tennessee, United States, 37203|
|Study Director:||Sandra Silberman, MD, PhD||Archer Biosciences, Inc.|