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
- 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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
90 days and 1 year post tx
William K. Kelly, DO
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Walter Reed Army Medical Center||Washington, District of Columbia 20307-5000|
|CCOP - Greenville||Greenville, South Carolina 29615|
|UMASS Memorial Cancer Center - University Campus||Worcester, Massachusetts 01605-2982|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University||Columbus, Ohio 43210-1240|
|Veterans Affairs Medical Center - Syracuse||Syracuse, New York 13210|
|Veterans Affairs Medical Center - Baltimore||Baltimore, Maryland 21201|
|SUNY Upstate Medical University Hospital||Syracuse, New York 13210|
|CCOP - Hematology-Oncology Associates of Central New York||East Syracuse, New York 13057|
|Wayne Memorial Hospital, Incorporated||Goldsboro, North Carolina 27534|
|Greenebaum Cancer Center at University of Maryland Medical Center||Baltimore, Maryland 21201|
|Lenoir Memorial Cancer Center||Kinston, North Carolina 28503-1678|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center||Washington, District of Columbia 20007|
|CCOP - Nevada Cancer Research Foundation||Las Vegas, Nevada 89109-2306|
|University Medical Center of Southern Nevada||Las Vegas, Nevada 89102|
|Oswego Hospital||Oswego, New York 13126|
|Community General Hospital of Greater Syracuse||Syracuse, New York 13215|
|Wayne Radiation Oncology||Goldsboro, North Carolina 27534|
|Wilson Medical Center||Wilson, North Carolina 27893-3428|
|Bon Secours St. Francis Health System||Greenville, South Carolina 29601|
|Danville Regional Medical Center||Danville, Virginia 24541|
|Saint Luke's Hospital||Chesterfield, Missouri 63017|
|Roper St. Francis Cancer Center at Roper Hospital||Charleston, South Carolina 29401|