A Study of Ixabepilone Before Surgery for High-Risk Localized Prostate Cancer
The purpose of this research study is to determine the safety and effectiveness of the investigational drug, Ixabepilone, in men with high risk prostate cancer who plan to receive surgery.
Prostate cancer is a common and important health issue facing men in the United States. Most patients with prostate cancer are identified when the disease is limited to the prostate gland itself (localized prostate cancer). A standard treatment for some patients with localized prostate cancer is removal of the prostate gland in an operation known as a "radical prostatectomy." A sub-set of patients with localized prostate cancer can be identified who are at high-risk of suffering a recurrence of prostate cancer after radical prostatectomy. For these patients, additional treatments are being investigated to combine with surgery in the hopes of increasing the chances for cure.
Several kinds of chemotherapy medicines have been used for advanced prostate cancer which returns after initial therapy. Epothilones are a newly developed class of chemotherapy drugs that appear promising for the treatment of many forms of cancer. Ixabepilone is drug in the epothilone class of chemotherapy medicines that has shown encouraging results for the treatment of advanced prostate cancer and other cancers in clinical trials.
This trial will include men with high-risk localized prostate cancer who will receive treatment with ixabepilone (4 cycles over 12 weeks) prior to radical prostatectomy. The goal of this trial will be to determine if analysis of genes and proteins in prostate cancer tissue taken before and after treatment can be used to predict ixabepilone response. In addition, this trial will evaluate the safety and feasibility of administering ixabepilone prior to radical prostatectomy for patients at high-risk of developing recurrent prostate cancer.
The study has three phases: Screening, Treatment and Follow-up
- Screening: Eligibility will be verified
- Treatment: Subjects will receive Ixabepilone, which will be administered every 21 days for 4 cycles prior to surgery
- Follow up: Subjects will be followed every 6 months for up to 5 years.
In addition, tissue will be collected at the time of surgery for genetic and protein studies. Blood will also be collected pre and post therapy for proteomic and/or genetic studies.
Genital Neoplasms, Male
Genital Diseases, Male
Neoplasms, Glandular and Epithelial
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Ixabepilone Prior to Surgery for High-risk Localized Prostate Cancer|
- To determine the biochemical response rate (defined as >/= 50% reduction in PSA from baseline to the post-therapy value) for non-castrate patients with localized prostate cancer and a >/= 30% risk of recurrence within 5 years. [ Time Frame: 4 cycles ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Study Completion Date:||August 2012|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Ixabepilone 35 mg/m^2 intravenously over 3 hours every 21 days for 4 cycles.
Other Name: BMS-247550
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672009
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Mitchell E Gross, MD, PhD||Cedars-Sinai Medical Center|