A Phase II Study of Taxotere (Docetaxel) Plus Adriamycin (Doxorubicin) and Prednisone (TAP) in Hormone-Refractory Prostate Cancer
OBJECTIVES:
Primary
- Assess prostate specific antigen response rate to docetaxel, doxorubicin hydrochloride,
and prednisone in patients with hormone-refractory advanced prostate cancer.
Secondary
- 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Frank M. Torti, MD, MPH
Study Chair
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
CCCWFU-85302
NCT00416533
August 2004
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