Clinical trial NCT00225420
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer
Sponsor: UNC Lineberger Comprehensive Cancer Center
Start date: 2005-08-01; Completion date: 2012-08-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
OBJECTIVES:

Primary

* 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.

Secondary

* 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.

Arms: arm 1: Single Arm Intervention where after enrollment (or prior to enrollment but before starting radiotherapy) patients will initially receive leuprolide acetate (Lupron®) intramuscular (IM). Patients will begin adaptive external-beam radiation therapy 2-3 months following the initiation of hormonal therapy. Each patient receives a dose of docetaxel at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight weeks.
Interventions: intervention 1: docetaxel intervention 2: leuprolide acetate intervention 3: radiation therapy
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: The total dose will be 7800 cGy in 200 centigray (cGy) per fraction for a total of 39 treatments.

Protocol documents: