Prostate Cancer Clinical Trial
Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer
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.
Full 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 Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate with one of the following prognostic factors:
Tx N0, baseline prostate specific antigen (PSA) greater than 20 ng/mL, and Gleason score at least 7
T3b-4 N0, any baseline PSA, and any Gleason score
No pelvic lymph node disease requiring pelvic radiotherapy
No metastatic disease by bone scan, CT scan, or MRI
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
ECOG 0-2
Life expectancy:
Not specified
Hematopoietic:
Granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hepatic:
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGOT no greater than 1.5 times ULN
Renal:
Creatinine no greater than 1.5 times ULN
Cardiovascular:
No significant cardiovascular disease
No New York Heart Association class III or IV congestive heart failure
No active angina pectoris
No myocardial infarction within the past 6 months
No history of hemorrhagic or thrombotic cerebral vascular accident
No deep vein thrombosis within the past 6 months
Pulmonary:
No pulmonary embolism within the past 6 months
Other:
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No prior immunotherapy for prostate cancer
No concurrent routine filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy:
No prior chemotherapy for prostate cancer
No other concurrent anticancer chemotherapy
Endocrine therapy:
No more than 6 weeks of prior androgen deprivation therapy
No other concurrent anticancer hormonal therapy except steroids for adrenal failure and/or hormones for nondisease-related conditions (e.g., insulin for diabetes)
Radiotherapy:
See Disease Characteristics
No prior radiotherapy for prostate cancer
No other concurrent anticancer radiotherapy
Surgery:
At least 4 weeks since prior major surgery
Other:
No prior alternative therapy (e.g., PC-SPES) for prostate cancer
No concurrent alternative medicine (e.g., PC-SPES or saw palmetto) or large quantities of vitamins
No other concurrent anticancer therapy
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There are 20 Locations for this study
Washington District of Columbia, 20007, United States
Washington District of Columbia, 20307, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21201, United States
Worcester Massachusetts, 01655, United States
Chesterfield Missouri, 63017, United States
Las Vegas Nevada, 89102, United States
Las Vegas Nevada, 89106, United States
New York New York, 10021, United States
Oswego New York, 13126, United States
Syracuse New York, 13057, United States
Syracuse New York, 13210, United States
Syracuse New York, 13210, United States
Syracuse New York, 13215, United States
Goldsboro North Carolina, 27534, United States
Goldsboro North Carolina, 27534, United States
Kinston North Carolina, 28501, United States
Wilson North Carolina, 27893, United States
Columbus Ohio, 43210, United States
Charleston South Carolina, 29401, United States
Greenville South Carolina, 29601, United States
Greenville South Carolina, 29615, United States
Danville Virginia, 24541, United States
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