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.

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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.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

34

Study ID:

NCT00016913

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 20 Locations for this study

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Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore Maryland, 21201, United States
Veterans Affairs Medical Center - Baltimore
Baltimore Maryland, 21201, United States
UMASS Memorial Cancer Center - University Campus
Worcester Massachusetts, 01655, United States
Saint Luke's Hospital
Chesterfield Missouri, 63017, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
Oswego Hospital
Oswego New York, 13126, United States
CCOP - Hematology-Oncology Associates of Central New York
Syracuse New York, 13057, United States
SUNY Upstate Medical University Hospital
Syracuse New York, 13210, United States
Veterans Affairs Medical Center - Syracuse
Syracuse New York, 13210, United States
Community General Hospital of Greater Syracuse
Syracuse New York, 13215, United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina, 27534, United States
Wayne Radiation Oncology
Goldsboro North Carolina, 27534, United States
Lenoir Memorial Cancer Center
Kinston North Carolina, 28501, United States
Wilson Medical Center
Wilson North Carolina, 27893, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus Ohio, 43210, United States
Roper St. Francis Cancer Center at Roper Hospital
Charleston South Carolina, 29401, United States
Bon Secours St. Francis Health System
Greenville South Carolina, 29601, United States
CCOP - Greenville
Greenville South Carolina, 29615, United States
Danville Regional Medical Center
Danville Virginia, 24541, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

34

Study ID:

NCT00016913

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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