Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer
| Status: | Archived |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
Phase I Trial of Concurrent Taxotere With Radiation Therapy and Hormonal Therapy For Clinically Localized High Risk 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.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
Click here to add this to my saved trials
