A Phase II Study Of Estramustine, Docetaxel, And Exisulind (IND #64733) In Men With Hormone Refractory Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- docetaxel
- Conditions
- Prostate Cancer
- Sponsor
- Alliance for Clinical Trials in Oncology
- Enrollment
- 80
- Locations
- 80
- Primary Endpoint
- Time to progression
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
OBJECTIVES: * 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Combined chemotherapy
combination of 3 chemotherapy agents for hormone refractory prostate cancer
Intervention: docetaxel
Combined chemotherapy
combination of 3 chemotherapy agents for hormone refractory prostate cancer
Intervention: estramustine phosphate sodium
Combined chemotherapy
combination of 3 chemotherapy agents for hormone refractory prostate cancer
Intervention: exisulind
Outcomes
Primary Outcomes
Time to progression
Time Frame: 24 months from study entry
Secondary Outcomes
- Changes in PSA(During treatment then q 3 mon until ds progression)
- Overall Survival(24 months from study entry)
- Toxicity(treatment up to 3 mon post treatment)