Phase
Condition
Prostate Cancer
Prostate Cancer, Early, Recurrent
Prostate Disorders
Treatment
docetaxel
ketoconazole
therapeutic hydrocortisone
Clinical Study ID
Ages 18-120 Male
Study Summary
Eligibility Criteria
Inclusion
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate that was continuously treated with androgen suppression
Rising prostate-specific antigen (PSA), defined as PSA > 5 ng/mL, rising on 2 consecutive measurements at least 4 weeks apart
Gleason score 7 or higher and/or seminal vesicle involvement at diagnosis
Patients previously treated with antiandrogen or glucocorticoid therapy must meet the following criteria:
Must show a continued rise in PSA after stopping antiandrogen (flutamide, bicalutamide, or nilutamide) or glucocorticoid (dexamethasone or prednisone)
At least 4 weeks continued rise in PSA after flutamide or nilutamide (6 weeks for bicalutamide)
Testosterone less than 50 ng/dL
Patients who have not undergone surgical castration must continue primary androgen suppression to maintain castrate levels of testosterone
No progressive or measurable local or metastatic disease (including bone metastases)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
Granulocyte count at least 2,000/mm^3
Platelet count at least 100,000/mm^3
Hepatic:
SGOT no greater than 2 times upper limit of normal
Bilirubin no greater than 1.5 mg/dL
Renal:
- Creatinine no greater than 1.7 mg/dL
Cardiovascular:
No American Heart Association class III or IV heart disease
No uncontrolled congestive heart failure
No life-threatening cardiac arrhythmias
Other:
Fertile patients must use effective contraception
No other prior malignancy unless curatively treated and disease-free for appropriate time period for specific cancer
No preexisting peripheral neuropathy greater than grade 1
No known hypersensitivity to polysorbate 80
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 5 years since prior systemic chemotherapy
Endocrine therapy:
See Disease Characteristics
At least 4 weeks since prior hydrocortisone
No prior ketoconazole
Radiotherapy:
At least 28 days since prior radiotherapy to primary site
No prior palliative radiotherapy
No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
Recovered form prior therapy
At least 7 days since prior parenteral antibiotics for active infection
No concurrent digitalis
No concurrent H_2 blockers or proton pump inhibitors (arm I only)
Concurrent bisphosphonates allowed provided they were initiated prior to study therapy
Study Design
Study Description
Connect with a study center
Comprehensive Cancer Institute
Huntsville, Alabama 35801
United StatesSite Not Available
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona 85259-5404
United StatesSite Not Available
Veterans Affairs Medical Center - Tucson
Tucson, Arizona 85723
United StatesSite Not Available
Veterans Affairs Medical Center - Little Rock
Little Rock, Arkansas 72205
United StatesSite Not Available
City of Hope Comprehensive Cancer Center
Duarte, California 91010-3000
United StatesSite Not Available
Rebecca and John Moores UCSD Cancer Center
La Jolla, California 92093-0658
United StatesSite Not Available
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California 94553
United StatesSite Not Available
Naval Medical Center - San Diego
San Diego, California 92134-3202
United StatesSite Not Available
UCSF Comprehensive Cancer Center
San Francisco, California 94115
United StatesSite Not Available
Medical Center of Aurora - South Campus
Aurora, Colorado 80012-0000
United StatesSite Not Available
Boulder Community Hospital
Boulder, Colorado 80301-9019
United StatesSite Not Available
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado 80933
United StatesSite Not Available
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado 80224
United StatesSite Not Available
Porter Adventist Hospital
Denver, Colorado 80210
United StatesSite Not Available
Presbyterian - St. Luke's Medical Center
Denver, Colorado 80218
United StatesSite Not Available
Rocky Mountain Cancer Centers - Denver Rose
Denver, Colorado 80220
United StatesSite Not Available
St. Joseph Hospital
Denver, Colorado 80218-1191
United StatesSite Not Available
Veterans Affairs Medical Center - Denver
Denver, Colorado 80220
United StatesSite Not Available
Swedish Medical Center
Englewood, Colorado 80112
United StatesSite Not Available
Sky Ridge Medical Center
Lone Tree, Colorado 80124
United StatesSite Not Available
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado 80501
United StatesSite Not Available
St. Mary-Corwin Regional Medical Center
Pueblo, Colorado 81004
United StatesSite Not Available
Rocky Mountain Cancer Centers - Thornton
Thornton, Colorado 80221
United StatesSite Not Available
Walter Reed Army Medical Center
Washington, District of Columbia 20307-5001
United StatesSite Not Available
Memorial Regional Cancer Center at Memorial Regional Hospital
Hollywood, Florida 33021
United StatesSite Not Available
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida 33612-9497
United StatesSite Not Available
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida 33612
United StatesSite Not Available
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia 30033
United StatesSite Not Available
MBCCOP - Hawaii
Honolulu, Hawaii 96813
United StatesSite Not Available
University of Chicago Cancer Research Center
Chicago, Illinois 60637-1470
United StatesSite Not Available
CCOP - Central Illinois
Decatur, Illinois 62526
United StatesSite Not Available
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois 62526
United StatesSite Not Available
Veterans Affairs Medical Center - Hines
Hines, Illinois 60141
United StatesSite Not Available
CCOP - Illinois Oncology Research Association
Peoria, Illinois 61615-7828
United StatesSite Not Available
West Suburban Center for Cancer Care
River Forest, Illinois 60305
United StatesSite Not Available
CCOP - Carle Cancer Center
Urbana, Illinois 61801
United StatesSite Not Available
Indiana University Cancer Center
Indianapolis, Indiana 46202-5289
United StatesSite Not Available
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana 46202
United StatesSite Not Available
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa 52403-1206
United StatesSite Not Available
Veterans Affairs Medical Center - Wichita
Wichita, Kansas 67218
United StatesSite Not Available
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky 40502-2236
United StatesSite Not Available
CCOP - Ochsner
New Orleans, Louisiana 70121
United StatesSite Not Available
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana 70112
United StatesSite Not Available
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana 70112
United StatesSite Not Available
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana 71101-4295
United StatesSite Not Available
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland 21201
United StatesSite Not Available
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland 21231
United StatesSite Not Available
Veterans Affairs Medical Center - Detroit
Detroit, Michigan 48201-1932
United StatesSite Not Available
CCOP - Kalamazoo
Kalamazoo, Michigan 49007-3731
United StatesSite Not Available
West Michigan Cancer Center
Kalamazoo, Michigan 49007
United StatesSite Not Available
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan 49085
United StatesSite Not Available
Mayo Clinic Cancer Center
Rochester, Minnesota 55905
United StatesSite Not Available
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi 39216
United StatesSite Not Available
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri 65203
United StatesSite Not Available
CCOP - Kansas City
Kansas City, Missouri 64131
United StatesSite Not Available
Missouri Baptist Cancer Center
Saint Louis, Missouri 63131
United StatesSite Not Available
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada 89106
United StatesSite Not Available
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett, New Hampshire 03106
United StatesSite Not Available
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756-0002
United StatesSite Not Available
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey 08903
United StatesSite Not Available
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico 87131
United StatesSite Not Available
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico 87108-5138
United StatesSite Not Available
Roswell Park Cancer Institute
Buffalo, New York 14263-0001
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center
New York, New York 10021
United StatesSite Not Available
Mount Sinai Medical Center
New York, New York 10029
United StatesSite Not Available
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York 10016
United StatesSite Not Available
Veterans Affairs Medical Center - Syracuse
Syracuse, New York 13210
United StatesSite Not Available
Cape Fear Valley Health System
Fayetteville, North Carolina 28302-2000
United StatesSite Not Available
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina 27534-9479
United StatesSite Not Available
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio 45220-2288
United StatesSite Not Available
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United StatesSite Not Available
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio 43210-1240
United StatesSite Not Available
CCOP - Columbus
Columbus, Ohio 43206
United StatesSite Not Available
Veterans Affairs Medical Center - Dayton
Dayton, Ohio 45428-1002
United StatesSite Not Available
CCOP - Toledo Community Hospital
Toledo, Ohio 43623-3456
United StatesSite Not Available
Oklahoma University Medical Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Veterans Affairs Medical Center - Portland
Portland, Oregon 97207
United StatesSite Not Available
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania 17822-2001
United StatesSite Not Available
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111-2497
United StatesSite Not Available
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina 29401-5799
United StatesSite Not Available
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota 57104
United StatesSite Not Available
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee 37232-6307
United StatesSite Not Available
Harrington Cancer Center
Amarillo, Texas 79106
United StatesSite Not Available
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas 79106
United StatesSite Not Available
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas 78229
United StatesSite Not Available
CCOP - Scott and White Hospital
Temple, Texas 76508
United StatesSite Not Available
Veterans Affairs Medical Center - Temple
Temple, Texas 76504
United StatesSite Not Available
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah 84148
United StatesSite Not Available
Martha Jefferson Hospital
Charlottesville, Virginia 22902
United StatesSite Not Available
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
Roanoke, Virginia 24014
United StatesSite Not Available
Veterans Affairs Medical Center - Seattle
Seattle, Washington 98108
United StatesSite Not Available
St. Mary's Medical Center
Huntington, West Virginia 25701
United StatesSite Not Available
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin 54307-3453
United StatesSite Not Available
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin 53792-0001
United StatesSite Not Available
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin 53226-3596
United StatesSite Not Available
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