|
|
|
|
|
|
Sponsors and Collaborators: |
University of Nebraska National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00482807 |
RATIONALE: Specialized radiation therapy that delivers a high- dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. 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. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and bicalutamide, may lessen the amount of androgens made by the body. Giving radiation therapy together with chemotherapy 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 together with intensity-modulated radiation therapy and hormone therapy in treating patients with high-risk locally advanced prostate cancer with pelvic lymph node metastasis.
Condition | Intervention | Phase |
Prostate Cancer |
Drug: bicalutamide Drug: docetaxel Drug: goserelin Procedure: intensity-modulated radiation therapy |
Phase I |
MedlinePlus related topics: | Cancer Prostate Cancer |
ChemIDplus related topics: | Docetaxel Goserelin Bicalutamide |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study Evaluating Extended Field Intensity Modulated Radiation Therapy and Docetaxel in Patients With Prostate Cancer Associated With Pelvic Node Metastasis |
Estimated Enrollment: | 15 |
Study Start Date: | August 2004 |
Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of docetaxel.
Patients receive combined androgen deprivation therapy (if not already on combined hormonal therapy) comprising goserelin acetate* subcutaneously once every 3 months for up to 2 years and oral bicalutamide once daily beginning on day 1 and continuing until the completion of radiotherapy. Beginning at approximately week 9 of androgen deprivation therapy, patients receive docetaxel IV over 1 hour once weekly for up to 9 weeks. Concurrently with chemotherapy, patients undergo intensity-modulated radiotherapy 5 days a week for up to 45 fractions (9 weeks).
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.
NOTE: *Not required for patients who have undergone bilateral orchiectomy
After completion of study therapy, patients are followed periodically for 5 years.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Locally advanced disease (T1 -T3b, N1 or N2, M0) at high risk for recurrence
Prior androgen suppression within the past 14 months is allowed provided the following criterion is met:
No biochemical evidence of PSA progression after androgen withdrawal
No evidence of distant metastasis, including any of the following:
PATIENT CHARACTERISTICS:
Meets 1 of the following criteria:
PRIOR CONCURRENT THERAPY:
United States, Nebraska | |||||
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |||||
Omaha, Nebraska, United States, 68198-6805 |
University of Nebraska |
National Cancer Institute (NCI) |
Study Chair: | Ralph Hauke, MD | University of Nebraska |
Investigator: | Elizabeth C. Reed, MD | University of Nebraska |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000547021, UNMC-19504 |
First Received: | June 4, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00482807 |
Health Authority: | United States: Federal Government |
|
|
|
|
|
|