Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00003915|
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : March 3, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: bicalutamide Drug: docetaxel Drug: estramustine phosphate sodium Drug: leuprolide acetate||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment|
|Study Start Date :||May 1999|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2018|
|Experimental: treatment||Drug: bicalutamide Drug: docetaxel Drug: estramustine phosphate sodium Drug: leuprolide acetate|
- PSA Progression Free Survival [ Time Frame: years ]
- overall survival [ Time Frame: years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003915
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Lahey Clinic - Burlington|
|Burlington, Massachusetts, United States, 01805|
|University of Massachusetts Memorial Medical Center - University Campus|
|Worcester, Massachusetts, United States, 01655|
|United States, New Hampshire|
|Norris Cotton Cancer Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|Principal Investigator:||William Walsh, MD||University of Massachusetts, Worcester|