Docetaxel, Androgen Ablation Therapy, and External-Beam Radiation Therapy in Treating Patients With High-Risk Localized 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. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x-rays to kill tumor cells. Giving docetaxel together with androgen ablation therapy and external-beam radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given together with androgen ablation therapy and external-beam radiation therapy and to see how well they work in treating patients with high-risk localized prostate cancer.
Drug: leuprolide acetate
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Concurrent Weekly Docetaxel (Taxotere®), Androgen Ablation, and Adaptive External Beam Radiotherapy for Localized High-Risk Adenocarcinoma of the Prostate|
- Progression-free survival [ Time Frame: when 3 consecutive rising PSA values have been noted ] [ Designated as safety issue: No ]PSA progression timepoint is defined as the midpoint between the last non-rising PSA and the first rising PSA.
- Survival [ Time Frame: until documentation of disease progression ] [ Designated as safety issue: No ]Time until there is clinical evidence of disease progression or recurrence on digital rectal examination
|Study Start Date:||August 2005|
|Study Completion Date:||August 2012|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.
Other Name: TaxotereDrug: leuprolide acetate
Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.
Other Names:Radiation: radiation therapy
The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments.
- Determine the dose-limiting toxicity and maximum tolerated dose of docetaxel when administered in combination with androgen ablation therapy and adaptive external-beam radiotherapy in patients with high-risk localized adenocarcinoma of the prostate.
- Determine the 2-year biochemical progression-free survival of patients treated with this regimen.
OUTLINE: This is a multicenter, open-label, dose-escalation study of docetaxel.
- Androgen ablation therapy: Patients receive leuprolide acetate or other luteinizing hormone-releasing hormone agonist beginning 2-3 months prior to the start of chemoradiotherapy and continuing for up to 2 years.
- Chemoradiotherapy: Patients receive docetaxel IV over 1 hour on day 1 and high-dose external-beam radiotherapy on days 1-5. Treatment repeats every 7 days for 8 courses 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.
After completion of study treatment, patients are followed every 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00225420
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Rex Cancer Center at Rex Hospital|
|Raleigh, North Carolina, United States, 27607|
|Principal Investigator:||Young Whang, MD, PhD||UNC Lineberger Comprehensive Cancer Center|