Hormone Therapy Compared With Combination Chemotherapy in Treating Patients With Prostate Cancer

NCT00027859 | Completed Phase 3 DMC

• 4 other identifiers: CDR0000069088E1899SWOG-E1899CALGB-E1899
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 98

Brief Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as ketoconazole may stop the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective than combination chemotherapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with that of combination chemotherapy in treating patients who have prostate cancer that has been previously treated with androgen suppression.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage III prostate cancer

Interventions

docetaxel DRUG

estramustine phosphate sodium DRUG

ketoconazole DRUG

therapeutic hydrocortisone DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• SWOG Cancer Research Network: collaborator
• Cancer and Leukemia Group B: collaborator

Study Sites (98)

Comprehensive Cancer Institute

Huntsville, Alabama, 35801, United States

Location

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Veterans Affairs Medical Center - Tucson

Tucson, Arizona, 85723, United States

Location

Veterans Affairs Medical Center - Little Rock

Little Rock, Arkansas, 72205, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Veterans Affairs Outpatient Clinic - Martinez

Martinez, California, 94553, United States

Location

Naval Medical Center - San Diego

San Diego, California, 92134-3202, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Medical Center of Aurora - South Campus

Aurora, Colorado, 80012-0000, United States

Location

Boulder Community Hospital

Boulder, Colorado, 80301-9019, United States

Location

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, 80933, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

St. Joseph Hospital

Denver, Colorado, 80218-1191, United States

Location

Presbyterian - St. Luke's Medical Center

Denver, Colorado, 80218, United States

Location

Rocky Mountain Cancer Centers - Denver Rose

Denver, Colorado, 80220, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

CCOP - Colorado Cancer Research Program, Incorporated

Denver, Colorado, 80224, United States

Location

Swedish Medical Center

Englewood, Colorado, 80112, United States

Location

Sky Ridge Medical Center

Lone Tree, Colorado, 80124, United States

Location

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, 80501, United States

Location

St. Mary-Corwin Regional Medical Center

Pueblo, Colorado, 81004, United States

Location

Rocky Mountain Cancer Centers - Thornton

Thornton, Colorado, 80221, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5001, United States

Location

Memorial Regional Cancer Center at Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

Veterans Affairs Medical Center - Tampa (Haley)

Tampa, Florida, 33612, United States

Location

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, Georgia, 30033, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Veterans Affairs Medical Center - Hines

Hines, Illinois, 60141, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615-7828, United States

Location

West Suburban Center for Cancer Care

River Forest, Illinois, 60305, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Veterans Affairs Medical Center - Indianapolis (Roudebush)

Indianapolis, Indiana, 46202, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

Veterans Affairs Medical Center - Wichita

Wichita, Kansas, 67218, United States

Location

Veterans Affairs Medical Center - Lexington

Lexington, Kentucky, 40502-2236, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Veterans Affairs Medical Center - New Orleans

New Orleans, Louisiana, 70112, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

Veterans Affairs Medical Center - Shreveport

Shreveport, Louisiana, 71101-4295, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Veterans Affairs Medical Center - Detroit

Detroit, Michigan, 48201-1932, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Veterans Affairs Medical Center - Jackson

Jackson, Mississippi, 39216, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

Missouri Baptist Cancer Center

St Louis, Missouri, 63131, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

New Hampshire Oncology-Hematology, PA - Hooksett

Hooksett, New Hampshire, 03106, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Veterans Affairs Medical Center - Albuquerque

Albuquerque, New Mexico, 87108-5138, United States

Location

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, 87131, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, 13210, United States

Location

Cape Fear Valley Health System

Fayetteville, North Carolina, 28302-2000, United States

Location

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, 27534-9479, United States

Location

Veterans Affairs Medical Center - Cincinnati

Cincinnati, Ohio, 45220-2288, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428-1002, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Veterans Affairs Medical Center - Portland

Portland, Oregon, 97207, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Abramson Cancer Center at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Veterans Affairs Medical Center - Charleston

Charleston, South Carolina, 29401-5799, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, 37232-6307, United States

Location

Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

Veterans Affairs Medical Center - Amarillo

Amarillo, Texas, 79106, United States

Location

Veterans Affairs Medical Center - San Antonio (Murphy)

San Antonio, Texas, 78229, United States

Location

Veterans Affairs Medical Center - Temple

Temple, Texas, 76504, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Veterans Affairs Medical Center - Salt Lake City

Salt Lake City, Utah, 84148, United States

Location

Martha Jefferson Hospital

Charlottesville, Virginia, 22902, United States

Location

Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke

Roanoke, Virginia, 24014, United States

Location

Veterans Affairs Medical Center - Seattle

Seattle, Washington, 98108, United States

Location

St. Mary's Medical Center

Huntington, West Virginia, 25701, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54307-3453, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-0001, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226-3596, United States

Location

Related Publications (1)

• Walczak JR, Carducci MA; Eastern Cooperative Oncology Group E1899. Phase 3 randomized trial evaluating second-line hormonal therapy versus docetaxel-estramustine combination chemotherapy on progression-free survival in asymptomatic patients with a rising prostate-specific antigen level after hormonal therapy for prostate cancer: an Eastern Cooperative Oncology Group (E1899), Intergroup/Clinical Trials Support Unit study. Urology. 2003 Dec 29;62 Suppl 1:141-6. doi: 10.1016/j.urology.2003.09.006.

  PMID: 14747052 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Estramustine; Ketoconazole; Hydrocortisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Michael A. Carducci, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

• Nirmala Bhoopalam, MD

  Veterans Affairs Medical Center - Hines

  STUDY CHAIR

• Gregory P. Swanson, MD

  Deaconess Medical Center, Spokane, Washington

  STUDY CHAIR

• William Dahut, MD

  National Cancer Institute (NCI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: December 7, 2001
• First Posted: January 27, 2003
• Study Start: October 8, 2003
• Primary Completion: December 1, 2004
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

US (98)