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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00016913 |
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 or leuprolide may stop the adrenal glands from producing androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, hormone therapy, and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying giving chemotherapy together with hormone therapy and radiation therapy in treating patients with locally advanced prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: carboplatin Drug: estramustine phosphate sodium Drug: goserelin Drug: leuprolide acetate Drug: paclitaxel Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study Of Neo-Adjuvant Paclitaxel, Estramustine And Carboplatin (TEC) Plus Androgen Ablation Prior To Radiation Therapy In Patients With Poor Prognosis Localized Prostate Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | May 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 1 hour once weekly; oral estramustine three times a day, five days a week; and carboplatin IV over 1 hour once monthly. Treatment repeats every 4 weeks for 4 courses.
Patients also receive gonadotropin-releasing hormonal therapy comprising either goserelin subcutaneously or leuprolide intramuscularly once monthly. Treatment repeats every 4 weeks for 6 courses.
After the completion of chemotherapy, patients undergo radiotherapy once daily on weeks 17-24.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1.5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate with one of the following prognostic factors:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, District of Columbia | |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
Washington, District of Columbia, United States, 20007 | |
Walter Reed Army Medical Center | |
Washington, District of Columbia, United States, 20307-5001 | |
United States, Maryland | |
Greenebaum Cancer Center at University of Maryland Medical Center | |
Baltimore, Maryland, United States, 21201 | |
Veterans Affairs Medical Center - Baltimore | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
UMASS Memorial Cancer Center - University Campus | |
Worcester, Massachusetts, United States, 01655 | |
United States, Missouri | |
Saint Luke's Hospital | |
Chesterfield, Missouri, United States, 63017 | |
United States, Nevada | |
CCOP - Nevada Cancer Research Foundation | |
Las Vegas, Nevada, United States, 89106 | |
University Medical Center of Southern Nevada | |
Las Vegas, Nevada, United States, 89102 | |
United States, New York | |
CCOP - Hematology-Oncology Associates of Central New York | |
Syracuse, New York, United States, 13057 | |
Community General Hospital of Greater Syracuse | |
Syracuse, New York, United States, 13215 | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
Oswego Hospital | |
Oswego, New York, United States, 13126 | |
SUNY Upstate Medical University Hospital | |
Syracuse, New York, United States, 13210 | |
Veterans Affairs Medical Center - Syracuse | |
Syracuse, New York, United States, 13210 | |
United States, North Carolina | |
Lenoir Memorial Cancer Center | |
Kinston, North Carolina, United States, 28501 | |
Wayne Memorial Hospital, Incorporated | |
Goldsboro, North Carolina, United States, 27534 | |
Wayne Radiation Oncology | |
Goldsboro, North Carolina, United States, 27534 | |
Wilson Medical Center | |
Wilson, North Carolina, United States, 27893-3428 | |
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
Columbus, Ohio, United States, 43210-1240 | |
United States, South Carolina | |
Bon Secours St. Francis Health System | |
Greenville, South Carolina, United States, 29601 | |
CCOP - Greenville | |
Greenville, South Carolina, United States, 29615 | |
Roper St. Francis Cancer Center at Roper Hospital | |
Charleston, South Carolina, United States, 29401 | |
United States, Virginia | |
Danville Regional Medical Center | |
Danville, Virginia, United States, 24541 |
Study Chair: | William K. Kelly, DO | Yale University |
Study ID Numbers: | CDR0000068632, CALGB-99811 |
Study First Received: | June 6, 2001 |
Last Updated: | November 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00016913 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage III prostate cancer |
Genital Neoplasms, Male Prostatic Diseases Estramustine Goserelin Urogenital Neoplasms Carboplatin Genital Diseases, Male Naphazoline |
Oxymetazoline Guaifenesin Paclitaxel Leuprolide Phenylephrine Phenylpropanolamine Adenocarcinoma Prostatic Neoplasms |
Antineoplastic Agents, Hormonal Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents Reproductive Control Agents Pharmacologic Actions Neoplasms |
Neoplasms by Site Therapeutic Uses Fertility Agents, Female Tubulin Modulators Fertility Agents Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents |