Epirubicin and Docetaxel in Treating Patients With Metastatic Prostate Cancer
RATIONALE: Drugs used in chemotherapy, such as epirubicin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of epirubicin when given with docetaxel in treating patients with metastatic prostate cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Trial of Epirubicin and Taxotere in Patients With Metastatic Androgen Independent Prostate Cancer|
|Study Start Date:||June 2004|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of epirubicin when administered with docetaxel in patients with metastatic, androgen-independent adenocarcinoma of the prostate.
- Determine the response rate (objective and prostate-specific antigen response) and duration of response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of epirubicin.
Patients receive epirubicin IV over 30 minutes and docetaxel IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of epirubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 18 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096304
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Andrew S. Kraft, MD||Medical University of South Carolina|