Bi-Weekly Administration of Docetaxel for Older Men With Hormone Refractory Prostate Cancer
This pilot study is designed to determine the feasibility and safety of administering docetaxel at various dosing levels on a bi-weekly schedule in older men with hormone refractory prostate cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Docetaxel on a Bi-Weekly Schedule in the Treatment of Elderly Men With Hormone-Refractory Prostate Cancer (HRPC)|
- To determine the maximum tolerated dose (MTD) of docetaxel on a bi-weekly schedule in the treatment of elderly men with hormonal refractory prostate cancer (HRPC).
- To determine the dose limiting toxicity effects and other toxic effects of this regimen
- To determine the activity of this regimen in terms of: Overall response rates; Pain scores and analgesic use; PSA response rates;
- To evaluate the feasibility of using a self-report geriatric assessment tool in this population
|Study Start Date:||July 2004|
|Study Completion Date:||July 2007|
The information obtained from this trial will help determine the feasibility and safety of administering docetaxel at various dosing levels on a bi-weekly schedule in this patient population. If the data from this phase I trial are encouraging, a phase II trial will be conducted to further assess the efficacy of this dosing schedule.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215709
|United States, Maryland|
|Baltimore, Maryland, United States, 21211|
|Principal Investigator:||William Ershler, MD||Geriatric Oncology Consortium|