Docetaxel, Doxorubicin, and Prednisone in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy
RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel, doxorubicin, and prednisone together works in treating patients with advanced prostate cancer that has not responded to hormone therapy.
Drug: doxorubicin hydrochloride
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Taxotere (Docetaxel) Plus Adriamycin (Doxorubicin) and Prednisone (TAP) in Hormone-Refractory Prostate Cancer|
|Study Start Date:||August 2004|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
- Assess prostate specific antigen response rate to docetaxel, doxorubicin hydrochloride, and prednisone in patients with hormone-refractory advanced prostate cancer.
- Assess if treatment with docetaxel, doxorubicin hydrochloride, and prednisone will improve health-related quality of life of these patients.
- Assess the toxicity of docetaxel, doxorubicin hydrochloride, and prednisone.
- Assess response rate in measurable disease.
OUTLINE: Patients receive docetaxel IV over 1 hour on day 1, doxorubicin hydrochloride IV over 15 minutes on days 1 and 8, and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 1 of each course, after completion of 3 courses, and at disease progression.
After completing study treatment, patients are followed every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416533
|Study Chair:||Frank M. Torti, MD, MPH||Wake Forest University Health Sciences|