Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2005-02-04
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as luteinizing hormone-releasing hormone agonist, flutamide, and bicalutamide may stop the adrenal glands from producing androgens. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy given at the same time as hormone therapy is more effective than chemotherapy given after hormone therapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given at the same time as hormone therapy with that of chemotherapy given after hormone therapy in treating patients who have prostate cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborators: Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; National Cancer Institute (NCI); NRG Oncology; Southwest Oncology Group
• Treatments: Androgens; Bicalutamide; Docetaxel; Doxorubicin; Estramustine; Flutamide; Hormones; Ketoconazole; Liposomal doxorubicin; Vinblastine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of adenocarcinoma of the prostate

• Failed local treatments (surgery and/or radiotherapy and/or brachytherapy) as defined by a rising prostate-specific antigen level of at least 2.0 ng/mL (confirmed by 2 measurements at least 2 weeks apart) and a doubling time of 32 weeks or less

• No clinical or radiographic evidence of disease

• Original Gleason score of at least 7 OR Gleason score of 6 with capsular penetration or positive seminal vesicles or lymph nodes

• No metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10 g/dL

• No history of bleeding disorders that would contraindicate warfarin, including clotting factor defects

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• AST/ALT no greater than 1.5 times upper limit of normal

Renal:

• Creatinine no greater than 1.5 mg/dL

• Blood Urea Nitrogen (BUN) no greater than 1.2 times normal

Cardiovascular:

• No symptomatic heart disease

• No history of myocardial infarction

• No history of thromboembolic events (e.g., deep vein thrombosis, symptomatic cerebrovascular events, or pulmonary embolism)

Other:

• No other major medical or psychiatric illness that would preclude study entry

• No other prior or concurrent invasive malignancy within the past 5 years except superficial skin cancer

• No history of esophageal varices

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 6 weeks since prior vaccine therapy

Chemotherapy:

• At least 5 years since prior chemotherapy

Endocrine therapy:

• Prior adjuvant or neoadjuvant hormonal therapy of less than 8 months duration allowed

• At least 1 year since prior androgen therapy

Radiotherapy:

• See Disease Characteristics

• At least 5 years since prior radiotherapy to sites other than prostate

Surgery:

• See Disease Characteristics

Other:

• Concurrent warfarin allowed

• Concurrent bisphosphonate therapy initiated prior to or after randomization allowed