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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
AUC=6 week one of each 4 week cycle
2 tablets tid PO 5 of 7 days per week each 4 week cycle
80 mg/sq m IV infusion over 1 hour weekly for ea 4 week cycle
77.4 Gy in 1.8 Gy fractions
7.5 mg IM injection once every 4 weeks for 6 months
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., 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
...and 13 more locations
Toxicity
Patients were evaluated for acute toxicities defined as grade 3 or greater cardiovascular (including venous thrombosis), gastrointestinal, or genitourinary toxicity occurring during the period starting from treatment initiation until 90 days or less after the completion of radiotherapy. The same toxicity measures were monitored at \>90 days after the completion of radiotherapy.
Time frame: 90 days and 1 year post treatment
Time to Prostate-specific Antigen Failure
PSA progression was defined in 2 ways. The CALGB PSA progression was defined as 2 consecutive rises in PSA with a rise of at least 0.2 ng/mL and above 1.0 ng/mL after radiation therapy; the date of PSA failure is taken as the midpoint between the last PSA before the rise and the first of the 2 PSAs that documented the rise. In addition, PSA progression was used according to the American Society for Therapeutic Radiology and Oncology 1996 (ASTRO) criteria and defined as 3 consecutive rises in PSA after radiation therapy. The date of PSA failure was taken as the midpoint between the time of the lowest PSA measure after irradiation and the first of the 3 consecutive rises.
Time frame: PSA was measured every 4 weeks during chemotherapy, at least every 12 weeks post radiation for 2 years, and every 6 months thereafter until PSA failure date (Up to 5.5 years).
Progression-free Survival (PFS)
PFS was defined as the time between treatment initiation and the date of disease progression (PSA, bone, tumor) or death, whichever occurred first. PSA progression is defined as 2 consecutive rising PSAs (a rise of at least 0.2 ng/mL) above 1.0 ng/mL.
Time frame: registration to progression, up to 5.5 years from registration
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