S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT00028769
- Lead Sponsor
- SWOG Cancer Research Network
- Brief 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. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Combining chemotherapy with hormone therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus hormone therapy in treating patients who have metastatic prostate cancer.
- Detailed Description
OBJECTIVES:
* Determine the progression-free and overall survival in patients with high-risk metastatic adenocarcinoma of the prostate treated with early estramustine, etoposide, and paclitaxel with combined androgen-blockade therapy.
* Determine the type, frequency, and severity of toxicity of this regimen in this patient population.
OUTLINE: This is a multicenter study.
* Androgen-blockade therapy: Patients receive a standard regimen of luteinizing hormone-releasing hormone agonist therapy comprising either goserelin subcutaneously once monthly or once every 3 months or leuprolide intramuscularly once monthly, once every 3 months, or once every 4 months. Patients also receive a standard regimen of antiandrogen therapy comprising oral bicalutamide, oral flutamide, or oral nilutamide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
* Chemotherapy: Beginning 14-30 days after initiation of androgen-blockade therapy, patients receive oral estramustine three times daily and oral etoposide once daily on days 1-14 and paclitaxel IV over 1 hour on day 2. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression, every 6 months for 2 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 41
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hormone therapy, estramustine, etoposide and paclitaxel bicalutamide Hormone therapy (leuprolide, bicalutamide, nilutamide, goserelin, flutamide), estramustine, etoposide and paclitaxel Hormone therapy, estramustine, etoposide and paclitaxel etoposide Hormone therapy (leuprolide, bicalutamide, nilutamide, goserelin, flutamide), estramustine, etoposide and paclitaxel Hormone therapy, estramustine, etoposide and paclitaxel flutamide Hormone therapy (leuprolide, bicalutamide, nilutamide, goserelin, flutamide), estramustine, etoposide and paclitaxel Hormone therapy, estramustine, etoposide and paclitaxel leuprolide Hormone therapy (leuprolide, bicalutamide, nilutamide, goserelin, flutamide), estramustine, etoposide and paclitaxel Hormone therapy, estramustine, etoposide and paclitaxel nilutamide Hormone therapy (leuprolide, bicalutamide, nilutamide, goserelin, flutamide), estramustine, etoposide and paclitaxel Hormone therapy, estramustine, etoposide and paclitaxel paclitaxel Hormone therapy (leuprolide, bicalutamide, nilutamide, goserelin, flutamide), estramustine, etoposide and paclitaxel Hormone therapy, estramustine, etoposide and paclitaxel estramustine Hormone therapy (leuprolide, bicalutamide, nilutamide, goserelin, flutamide), estramustine, etoposide and paclitaxel Hormone therapy, estramustine, etoposide and paclitaxel goserelin Hormone therapy (leuprolide, bicalutamide, nilutamide, goserelin, flutamide), estramustine, etoposide and paclitaxel
- Primary Outcome Measures
Name Time Method Progression-free Survival 0-5 years (assessed every 3 months if no progression when the chemotherapy had been finished. Once off chemotherapy, assessed every 3 months until progression) Measured from time of registration to time of first documentation of progression determined from the prostate-specific antigen (PSA) level, clinical criteria, or symptomatic deterioration. PSA progression is defined as a 25% increase greater than baseline. If the patient's PSA level had decrease during the study, a 25% increase from the nadir PSA level, with absolute value of \>=5 ng/mL is considered progression. CLinical progress is defined as the appearance of any new lesion at any site or death without documented progression. Symptomatic deterioration is defined as a global deterioration of the health status requiring discontinuation of treatment without objective evidence of progression.
Overall Survival (OS) 0-5 years Overall survival is defined from the date of registration to date of death from any cause
- Secondary Outcome Measures
Name Time Method Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug up to 5 years after registration Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Trial Locations
- Locations (91)
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
🇺🇸Shreveport, Louisiana, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus
🇺🇸Southfield, Michigan, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Cancer Research Center at Boston Medical Center
🇺🇸Boston, Massachusetts, United States
M.D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Huntsman Cancer Institute at University of Utah
🇺🇸Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
Saint Louis University Cancer Center
🇺🇸Saint Louis, Missouri, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Puget Sound Oncology Consortium
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - Charleston
🇺🇸Charleston, South Carolina, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
Veterans Affairs Medical Center - Little Rock
🇺🇸Little Rock, Arkansas, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Veterans Affairs Medical Center - West Los Angeles
🇺🇸Los Angeles, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸Orange, California, United States
MBCCOP - Howard University Cancer Center
🇺🇸Washington, District of Columbia, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago Westside Hospital
🇺🇸Chicago, Illinois, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Veterans Affairs Medical Center - Hines
🇺🇸Hines, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Tulane Cancer Center at Tulane University Hospital and Clinic
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Jackson
🇺🇸Jackson, Mississippi, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
CCOP - Beaumont
🇺🇸Royal Oak, Michigan, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
NYU Cancer Institute at New York University Medical Center
🇺🇸New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
Western New York Urology Associates
🇺🇸Cheektowaga, New York, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Goldsboro, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Tennessee Cancer Institute at Methodist Central Hospital
🇺🇸Memphis, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine
🇺🇸Amarillo, Texas, United States
Veterans Affairs Medical Center - Amarillo
🇺🇸Amarillo, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
UMC Southwest Cancer and Research Center
🇺🇸Lubbock, Texas, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Sentara Cancer Institute at Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
🇺🇸Phoenix, Arizona, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Aurora, Colorado, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Tampa (Haley)
🇺🇸Tampa, Florida, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Veterans Affairs Medical Center - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States