Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Docetaxel may also make tumor cells more sensitive to radiation therapy. Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, or bicalutamide, may stop the adrenal glands from making androgens. Giving chemotherapy with radiation therapy and hormone therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given with radiation therapy and hormone therapy in patients with locally advanced prostate cancer.
Drug: goserelin acetate
Drug: leuprolide acetate
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Trial of Concurrent Taxotere With Radiation Therapy and Hormonal Therapy For Clinically Localized High Risk Prostate Cancer|
|Study Start Date:||July 2004|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
- 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 annually therafter.
PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study.
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Study Chair:||Andrew S. Kraft, MD||Medical University of South Carolina|