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

Sponsor
Eastern Cooperative Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00027859
Collaborator
National Cancer Institute (NCI) (NIH), Southwest Oncology Group (Other), Cancer and Leukemia Group B (Other)
98
Locations

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

OBJECTIVES:

  • Compare time to objective progression in patients with prostate cancer and a rising prostate-specific antigen (PSA) after androgen suppression when treated with second-line hormonal therapy (ketoconazole and hydrocortisone) vs combination chemotherapy (docetaxel and estramustine).

  • Compare time to PSA progression and correlate this with time to objective progression in patients treated with these regimens.

  • Compare the quality of life in patients treated with these regimens.

  • Compare overall survival of patients treated with these regimens.

  • Compare the natural history of progression in patients treated with these regimens.

  • Identify prognostic indicators of clinical outcome by immunohistochemical evaluation of apoptopic biomarkers in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior treatment with bisphosphonates (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral ketoconazole three times daily and oral hydrocortisone twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

  • Arm II: Patients receive oral estramustine three times daily on days 1-5 and docetaxel IV over 1 hour on day 2. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, on day 1 of week 9, at 6 months and 1 year, and then annually for up to 10 years or until beginning of first non-protocol therapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 590 patients (295 per treatment arm) will be accrued for this study within 4 years.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Primary Purpose:
Treatment
Official Title:
A Phase III Randomized Trial for Evaluating Second Line Hormonal Therapy (Ketoconazole/Hydrocortisone) Versus Paclitaxel/Estramustine Combination Chemotherapy on Progression Free Survival in Asymptomatic Patients With a Rising PSA After Hormonal Therapy for Prostate Cancer
Study Start Date :
May 1, 2003
Actual Primary Completion Date :
Dec 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Comprehensive Cancer Institute Huntsville Alabama United States 35801
    2 CCOP - Mayo Clinic Scottsdale Oncology Program Scottsdale Arizona United States 85259-5404
    3 Veterans Affairs Medical Center - Tucson Tucson Arizona United States 85723
    4 Veterans Affairs Medical Center - Little Rock Little Rock Arkansas United States 72205
    5 City of Hope Comprehensive Cancer Center Duarte California United States 91010-3000
    6 Rebecca and John Moores UCSD Cancer Center La Jolla California United States 92093-0658
    7 Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center Los Angeles California United States 90048
    8 Veterans Affairs Outpatient Clinic - Martinez Martinez California United States 94553
    9 Naval Medical Center - San Diego San Diego California United States 92134-3202
    10 UCSF Comprehensive Cancer Center San Francisco California United States 94115
    11 Medical Center of Aurora - South Campus Aurora Colorado United States 80012-0000
    12 Boulder Community Hospital Boulder Colorado United States 80301-9019
    13 Penrose Cancer Center at Penrose Hospital Colorado Springs Colorado United States 80933
    14 Porter Adventist Hospital Denver Colorado United States 80210
    15 St. Joseph Hospital Denver Colorado United States 80218-1191
    16 Presbyterian - St. Luke's Medical Center Denver Colorado United States 80218
    17 Rocky Mountain Cancer Centers - Denver Rose Denver Colorado United States 80220
    18 Veterans Affairs Medical Center - Denver Denver Colorado United States 80220
    19 CCOP - Colorado Cancer Research Program, Incorporated Denver Colorado United States 80224
    20 Swedish Medical Center Englewood Colorado United States 80112
    21 Sky Ridge Medical Center Lone Tree Colorado United States 80124
    22 Hope Cancer Care Center at Longmont United Hospital Longmont Colorado United States 80501
    23 St. Mary-Corwin Regional Medical Center Pueblo Colorado United States 81004
    24 Rocky Mountain Cancer Centers - Thornton Thornton Colorado United States 80221
    25 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5001
    26 Memorial Regional Cancer Center at Memorial Regional Hospital Hollywood Florida United States 33021
    27 H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa Florida United States 33612-9497
    28 Veterans Affairs Medical Center - Tampa (Haley) Tampa Florida United States 33612
    29 Veterans Affairs Medical Center - Atlanta (Decatur) Decatur Georgia United States 30033
    30 MBCCOP - Hawaii Honolulu Hawaii United States 96813
    31 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
    32 CCOP - Central Illinois Decatur Illinois United States 62526
    33 Decatur Memorial Hospital Cancer Care Institute Decatur Illinois United States 62526
    34 Veterans Affairs Medical Center - Hines Hines Illinois United States 60141
    35 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61615-7828
    36 West Suburban Center for Cancer Care River Forest Illinois United States 60305
    37 CCOP - Carle Cancer Center Urbana Illinois United States 61801
    38 Indiana University Cancer Center Indianapolis Indiana United States 46202-5289
    39 Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis Indiana United States 46202
    40 CCOP - Cedar Rapids Oncology Project Cedar Rapids Iowa United States 52403-1206
    41 Veterans Affairs Medical Center - Wichita Wichita Kansas United States 67218
    42 Veterans Affairs Medical Center - Lexington Lexington Kentucky United States 40502-2236
    43 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
    44 Veterans Affairs Medical Center - New Orleans New Orleans Louisiana United States 70112
    45 CCOP - Ochsner New Orleans Louisiana United States 70121
    46 Veterans Affairs Medical Center - Shreveport Shreveport Louisiana United States 71101-4295
    47 Greenebaum Cancer Center at University of Maryland Medical Center Baltimore Maryland United States 21201
    48 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231
    49 Veterans Affairs Medical Center - Detroit Detroit Michigan United States 48201-1932
    50 CCOP - Kalamazoo Kalamazoo Michigan United States 49007-3731
    51 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    52 Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph Saint Joseph Michigan United States 49085
    53 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    54 Veterans Affairs Medical Center - Jackson Jackson Mississippi United States 39216
    55 Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri United States 65203
    56 CCOP - Kansas City Kansas City Missouri United States 64131
    57 Missouri Baptist Cancer Center Saint Louis Missouri United States 63131
    58 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    59 New Hampshire Oncology-Hematology, PA - Hooksett Hooksett New Hampshire United States 03106
    60 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756-0002
    61 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick New Jersey United States 08903
    62 Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico United States 87108-5138
    63 MBCCOP - University of New Mexico HSC Albuquerque New Mexico United States 87131
    64 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
    65 NYU School of Medicine's Kaplan Comprehensive Cancer Center New York New York United States 10016
    66 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    67 Mount Sinai Medical Center New York New York United States 10029
    68 Veterans Affairs Medical Center - Syracuse Syracuse New York United States 13210
    69 Cape Fear Valley Health System Fayetteville North Carolina United States 28302-2000
    70 CCOP - Southeast Cancer Control Consortium Goldsboro North Carolina United States 27534-9479
    71 Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio United States 45220-2288
    72 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    73 CCOP - Columbus Columbus Ohio United States 43206
    74 Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus Ohio United States 43210-1240
    75 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428-1002
    76 CCOP - Toledo Community Hospital Toledo Ohio United States 43623-3456
    77 Oklahoma University Medical Center Oklahoma City Oklahoma United States 73104
    78 Veterans Affairs Medical Center - Portland Portland Oregon United States 97207
    79 CCOP - Geisinger Clinic and Medical Center Danville Pennsylvania United States 17822-2001
    80 Abramson Cancer Center at the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    81 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111-2497
    82 Western Pennsylvania Hospital Pittsburgh Pennsylvania United States 15224
    83 Veterans Affairs Medical Center - Charleston Charleston South Carolina United States 29401-5799
    84 CCOP - Sioux Community Cancer Consortium Sioux Falls South Dakota United States 57104
    85 Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center Nashville Tennessee United States 37232-6307
    86 Harrington Cancer Center Amarillo Texas United States 79106
    87 Veterans Affairs Medical Center - Amarillo Amarillo Texas United States 79106
    88 Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas United States 78229
    89 Veterans Affairs Medical Center - Temple Temple Texas United States 76504
    90 CCOP - Scott and White Hospital Temple Texas United States 76508
    91 Veterans Affairs Medical Center - Salt Lake City Salt Lake City Utah United States 84148
    92 Martha Jefferson Hospital Charlottesville Virginia United States 22902
    93 Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke Roanoke Virginia United States 24014
    94 Veterans Affairs Medical Center - Seattle Seattle Washington United States 98108
    95 St. Mary's Medical Center Huntington West Virginia United States 25701
    96 CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay Wisconsin United States 54307-3453
    97 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792-0001
    98 Medical College of Wisconsin Cancer Center Milwaukee Wisconsin United States 53226-3596

    Sponsors and Collaborators

    • Eastern Cooperative Oncology Group
    • National Cancer Institute (NCI)
    • Southwest Oncology Group
    • Cancer and Leukemia Group B

    Investigators

    • Study Chair: 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00027859
    Other Study ID Numbers:
    • CDR0000069088
    • E1899
    • SWOG-E1899
    • CALGB-E1899
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jan 27, 2010
    Last Verified:
    Jan 1, 2010
    Keywords provided by , ,
    adenocarcinoma of the prostate
    stage III prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Ketoconazole
    Hydrocortisone
    Hydrocortisone 17-butyrate 21-propionate
    Hydrocortisone acetate
    Hydrocortisone hemisuccinate
    Docetaxel
    Estramustine

    Study Results

    No Results Posted as of Jan 27, 2010