Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments bicalutamide, docetaxel, estramustine phosphate sodium, leuprolide acetate
Phase phase 2
Sponsor University of Massachusetts, Worcester
Start date May 1999
End date February 2015
Trial size 63 participants
Trial identifier NCT00003915, CDR0000067095, NCI-V99-1546, UMASS-H-3745

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide and leuprolide may fight prostate cancer by reducing the production of androgens.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy consisting of docetaxel and estramustine plus hormone therapy in treating patients who have previously undergone radiation therapy or surgical removal of the prostate for stage I prostate cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
bicalutamide
docetaxel
estramustine phosphate sodium
leuprolide acetate

Primary Outcomes

Measure
PSA Progression Free Survival
time frame: years

Secondary Outcomes

Measure
overall survival
time frame: years

Eligibility Criteria

Male participants of any age.

DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - No metastases - No measurable or evaluable disease - 2 consecutively rising PSA levels at least 2 weeks apart, despite prior radical prostatectomy or radiotherapy (external beam or implant) - PSA risen to twice nadir value post radiotherapy PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - Must meet 1 of the following criteria: - SGOT and/or SGPT no greater than 2.5 times ULN AND alkaline phosphatase no greater than ULN - Alkaline phosphatase no greater than 4.0 times ULN AND SGOT and/or SGPT no greater than ULN - SGOT and SGPT no greater than 1.5 times ULN AND alkaline phosphatase no greater than 2.5 times ULN Renal: - Not specified Cardiovascular: - At least 6 months since prior myocardial infarction, angina, or New York Heart Association class III or IV heart disease - No active thrombophlebitis - At least 6 months since prior thromboembolic events including deep vein thrombosis and cerebrovascular accident Other: - No other malignancies within the past 5 years except curatively treated basal cell skin cancer - No active infection - No significant neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior estramustine or suramin Endocrine therapy: - At least 6 months since prior neoadjuvant or adjuvant hormonal therapy of no greater than 6 months duration - No concurrent corticosteroids Radiotherapy: - Salvage radiotherapy post prostatectomy allowed Surgery: - See Disease Characteristics

Additional Information

Official title Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment
Principal investigator William Walsh, MD
Description OBJECTIVES: - Determine the feasibility of administering docetaxel plus estramustine in combination with androgen deprivation therapy in patients with PSA elevation following radiotherapy or radical prostatectomy for early prostate cancer. - Evaluate this regimen in terms of PSA response rate, response duration, and time to future therapeutic intervention in this patient population. - Evaluate testosterone, free testosterone, and sex hormone binding globulin in relation to this treatment regimen in these patients. OUTLINE: Patients receive oral estramustine three times a day on days 1-5 and docetaxel IV over 1 hour on day 2. Treatment repeats every 3 weeks for 4 courses. Patients receive oral bicalutamide daily beginning on week 12 and leuprolide intramuscularly every 3 months beginning on week 13. Treatment continues for 15 months. Patients are followed every 3 months for 2 years, every 4 months for 1 year, and every 6 months thereafter until disease progression and/or subsequently until death. Information will be collected on subsequent prostate cancer treatments, time to and nature of first evidence of metastatic prostate cancer, and the date and cause of death. PROJECTED ACCRUAL: Approximately 55 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by University of Massachusetts, Worcester.