Spots Global Cancer Trial Database for Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer
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Trial Identification
Brief Title: Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer
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
Study ID: NCT00016913
Conditions
Study Description
Brief 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 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.
Detailed Description: OBJECTIVES: * Determine the feasibility and safety of paclitaxel, estramustine, carboplatin, and androgen ablation followed by radiotherapy in patients with poor-prognosis locally advanced prostate cancer. * Determine the progression-free survival and time to prostate specific antigen failure in patients treated with this regimen. 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
Veterans Affairs Medical Center - Baltimore, Baltimore, Maryland, United States
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, United States
Saint Luke's Hospital, Chesterfield, Missouri, United States
University Medical Center of Southern Nevada, Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Oswego Hospital, Oswego, New York, United States
CCOP - Hematology-Oncology Associates of Central New York, Syracuse, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse, Syracuse, New York, United States
Community General Hospital of Greater Syracuse, Syracuse, New York, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Wayne Radiation Oncology, Goldsboro, North Carolina, United States
Lenoir Memorial Cancer Center, Kinston, North Carolina, United States
Wilson Medical Center, Wilson, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, United States
Roper St. Francis Cancer Center at Roper Hospital, Charleston, South Carolina, United States
Bon Secours St. Francis Health System, Greenville, South Carolina, United States
CCOP - Greenville, Greenville, South Carolina, United States
Danville Regional Medical Center, Danville, Virginia, United States
Contact Details
Name: William K. Kelly, DO
Affiliation: Yale University
Role: STUDY_CHAIR
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