Phase I Trial of Concurrent Taxotere With Radiation Therapy and Hormonal Therapy For Clinically Localized High Risk Prostate Cancer
- Determine the maximum tolerated dose of docetaxel, when given in combination with
radiotherapy and hormonal therapy, in patients with high-risk clinically locally
advanced prostate cancer.
- Determine progression-free survival and time to prostate-specific antigen failure in
patients treated with this regimen.
OUTLINE: This is a dose-escalation study of docetaxel.
Patients receive goserelin subcutaneously (SC) OR leuprolide intramuscularly (IM) once
monthly AND oral bicalutamide once daily for 2 months. Patients then receive docetaxel IV
over 30 minutes on days 1, 8, 15, 22, 29, 36, 43, 50, and 57. Concurrent with chemotherapy,
patients undergo radiotherapy on days 1-5 weekly for 8.6 weeks (43 fractions). Patients
continue to receive goserelin SC OR leuprolide IM once monthly during chemotherapy and
radiotherapy and then every 3 months for 2 years. Treatment continues in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of docetaxel 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 2 years, every 6 months for 4 years, and then
PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study.
Primary Purpose: Treatment
Andrew S. Kraft, MD
Medical University of South Carolina
United States: Food and Drug Administration
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|