Prostate Cancer Clinical Trial
Official title:
A Phase II Study of Taxotere (Docetaxel) Plus Adriamycin (Doxorubicin) and Prednisone (TAP) in Hormone-Refractory Prostate Cancer
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.
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.
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