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S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer

Information source: Southwest Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: bicalutamide (Drug); estramustine (Drug); etoposide (Drug); flutamide (Drug); goserelin (Drug); leuprolide (Drug); nilutamide (Drug); paclitaxel (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Southwest Oncology Group

Official(s) and/or principal investigator(s):
David C. Smith, MD, Study Chair, Affiliation: University of Michigan Cancer Center

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.

Clinical Details

Official title: Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Combination With Hormone Therapy in Patients With High-Risk Metastatic Adenocarinoma of the Prostate

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Progression-free Survival

Overall Survival (OS)

Secondary outcome: Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed high-risk adenocarcinoma of the prostate

- Clinical stage D2 disease as evidenced by one of the following:

- Visceral disease (liver, lung, or other viscera)

- Bone metastases to sites in both the axial (spine, pelvis, ribs, or skull)

and appendicular (claviculae, humeri, or femora) skeleton

- No prior or concurrent (treated or untreated) brain metastases

- Patients with clinical evidence of brain metastasis must have a negative brain

CT or MRI

- No evidence of untreated spinal cord compression

PATIENT CHARACTERISTICS: Age:

- Over 18

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- No active hypercoagulability

Hepatic:

- Not specified

Renal:

- Not specified

Cardiovascular:

- No transient ischemic attacks, stroke, or myocardial infarction within the past 6

months

- No active coronary artery disease requiring antianginal therapy

- No active thrombophlebitis

Pulmonary:

- No history of pulmonary embolus

Other:

- No other prior malignancy within the past 5 years except adequately treated basal

cell or squamous cell skin cancer or adequately treated stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy:

- At least 4 weeks since prior biologic therapy and recovered

- No concurrent biologic therapy

Chemotherapy:

- No prior cytotoxic chemotherapy

- No other concurrent chemotherapy

Endocrine therapy:

- Prior androgen-blockade therapy (e. g., luteinizing hormone-releasing hormone agonist

and antiandrogen therapy) allowed if administered for a duration of less than 30 days

- Prior neoadjuvant hormonal therapy allowed

Radiotherapy:

- At least 4 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy

Surgery:

- At least 4 weeks since prior surgery and recovered

Other:

- No concurrent bisphosphonates

Locations and Contacts

MBCCOP - Gulf Coast, Mobile, Alabama 36607, United States

CCOP - Western Regional, Arizona, Phoenix, Arizona 85006-2726, United States

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona 85012, United States

Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona 85724, United States

Veterans Affairs Medical Center - Tucson, Tucson, Arizona 85723, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

Veterans Affairs Medical Center - Little Rock, Little Rock, Arkansas 72205, United States

City of Hope Comprehensive Cancer Center, Duarte, California 91010-3000, United States

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California 90033, United States

Veterans Affairs Medical Center - West Los Angeles, Los Angeles, California 90073, United States

Veterans Affairs Outpatient Clinic - Martinez, Martinez, California 94553, United States

CCOP - Bay Area Tumor Institute, Oakland, California 94609-3305, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California 92868, United States

University of California Davis Cancer Center, Sacramento, California 95817, United States

CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California 95403, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado 80010, United States

Veterans Affairs Medical Center - Denver, Denver, Colorado 80220, United States

MBCCOP - Howard University Cancer Center, Washington, District of Columbia 20060, United States

Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida 33612, United States

CCOP - Atlanta Regional, Atlanta, Georgia 30342-1701, United States

MBCCOP - Hawaii, Honolulu, Hawaii 96813, United States

MBCCOP - University of Illinois at Chicago, Chicago, Illinois 60612, United States

Veterans Affairs Medical Center - Chicago Westside Hospital, Chicago, Illinois 60612, United States

CCOP - Central Illinois, Decatur, Illinois 62526, United States

Veterans Affairs Medical Center - Hines, Hines, Illinois 60141, United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois 60153-5500, United States

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas 66160-7390, United States

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

Veterans Affairs Medical Center - Wichita, Wichita, Kansas 67218, United States

Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky 40536-0084, United States

Veterans Affairs Medical Center - Lexington, Lexington, Kentucky 40502-2236, United States

MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana 70112, United States

Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana 70112, United States

Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana 70112, United States

Feist-Weiller Cancer Center at Louisiana State University Health Sciences, Shreveport, Louisiana 71130-3932, United States

Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana 71101-4295, United States

Cancer Research Center at Boston Medical Center, Boston, Massachusetts 02118, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan 48109-0946, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States

Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan 48202, United States

Veterans Affairs Medical Center - Detroit, Detroit, Michigan 48201-1932, United States

CCOP - Grand Rapids, Grand Rapids, Michigan 49503, United States

CCOP - Beaumont, Royal Oak, Michigan 48073-6769, United States

Providence Cancer Institute at Providence Hospital - Southfield Campus, Southfield, Michigan 48075, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216-4505, United States

Veterans Affairs Medical Center - Jackson, Jackson, Mississippi 39216, United States

CCOP - Kansas City, Kansas City, Missouri 64131, United States

CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri 63141, United States

Saint Louis University Cancer Center, Saint Louis, Missouri 63110, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri 65807, United States

CCOP - Montana Cancer Consortium, Billings, Montana 59101, United States

MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico 87131, United States

Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico 87108-5138, United States

Western New York Urology Associates, Cheektowaga, New York 14225, United States

Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York 10032, United States

NYU Cancer Institute at New York University Medical Center, New York, New York 10016, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York 14642, United States

CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina 27534-9479, United States

Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio 45267-0501, United States

Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio 45220-2288, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195-9001, United States

CCOP - Columbus, Columbus, Ohio 43206, United States

CCOP - Dayton, Dayton, Ohio 45429, United States

Veterans Affairs Medical Center - Dayton, Dayton, Ohio 45428-1002, United States

Oklahoma University Medical Center, Oklahoma City, Oklahoma 73104, United States

Cancer Institute at Oregon Health and Science University, Portland, Oregon 97201-3098, United States

CCOP - Columbia River Oncology Program, Portland, Oregon 97225, United States

Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina 29425, United States

Veterans Affairs Medical Center - Charleston, Charleston, South Carolina 29401-5799, United States

CCOP - Greenville, Greenville, South Carolina 29615, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States

University of Tennessee Cancer Institute at Methodist Central Hospital, Memphis, Tennessee 38104, United States

Harrington Cancer Center, Amarillo, Texas 79106, United States

Texas Tech University Health Sciences Center School of Medicine, Amarillo, Texas 79106, United States

Veterans Affairs Medical Center - Amarillo, Amarillo, Texas 79106, United States

Brooke Army Medical Center, Fort Sam Houston, Texas 78234-6200, United States

University of Texas Medical Branch, Galveston, Texas 77555-0565, United States

Baylor College of Medicine, Houston, Texas 77030, United States

M.D. Anderson Cancer Center at University of Texas, Houston, Texas 77030-4095, United States

UMC Southwest Cancer and Research Center, Lubbock, Texas 79415-3364, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229-3900, United States

CCOP - Scott and White Hospital, Temple, Texas 76508, United States

Veterans Affairs Medical Center - Temple, Temple, Texas 76504, United States

Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah 84132, United States

Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah 84148, United States

Sentara Cancer Institute at Sentara Norfolk General Hospital, Norfolk, Virginia 23510-1115, United States

CCOP - Virginia Mason Research Center, Seattle, Washington 98101, United States

Puget Sound Oncology Consortium, Seattle, Washington 98109, United States

Veterans Affairs Medical Center - Seattle, Seattle, Washington 98108, United States

CCOP - Northwest, Tacoma, Washington 98405-0986, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: December 2001
Last updated: June 12, 2013

Page last updated: August 23, 2015

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