Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Estramustine may fight prostate cancer by reducing the production of androgens. Exisulind may stop the growth of prostate cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining these therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining estramustine with exisulind and docetaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Drug: estramustine phosphate sodium
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Estramustine, Docetaxel, And Exisulind (IND #64733) In Men With Hormone Refractory Prostate Cancer|
- Time to progression [ Time Frame: 24 months from study entry ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: treatment up to 3 mon post treatment ] [ Designated as safety issue: Yes ]
- Changes in PSA [ Time Frame: During treatment then q 3 mon until ds progression ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 24 months from study entry ] [ Designated as safety issue: No ]
|Study Start Date:||November 2002|
|Study Completion Date:||April 2009|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
Experimental: Combined chemotherapy
combination of 3 chemotherapy agents for hormone refractory prostate cancer
70 mg/sq m IV infusion over 1 hour Day 2 of ea cycleDrug: estramustine phosphate sodium
280 mg PO tid Days 1-5 of ea cycleDrug: exisulind
Two 125 mg capsules PO bid Days 1-21 of ea cycle
- Determine the time to objective and biochemical progression and response proportion (objective and post-therapy changes in PSA) in patients with hormone refractory metastatic prostate cancer treated with docetaxel, estramustine, and exisulind.
- Determine the toxic effects of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: Patients receive oral estramustine 3 times daily on days 1-5, docetaxel IV over 1 hour on day 2, and oral exisulind twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 18 months.