S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Male

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, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Combining chemotherapy with hormone therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus hormone therapy in treating patients who have metastatic prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Bicalutamide; Estramustine; Etoposide; Etoposide phosphate; Flutamide; Goserelin; Hormones; Leuprolide; Nilutamide; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed high-risk adenocarcinoma of the prostate

• Clinical stage D2 disease as evidenced by one of the following:

• Visceral disease (liver, lung, or other viscera)

• Bone metastases to sites in both the axial (spine, pelvis, ribs, or skull) and appendicular (claviculae, humeri, or femora) skeleton

• No prior or concurrent (treated or untreated) brain metastases

• Patients with clinical evidence of brain metastasis must have a negative brain CT or MRI

• No evidence of untreated spinal cord compression

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

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

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

• No active hypercoagulability

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• No transient ischemic attacks, stroke, or myocardial infarction within the past 6 months

• No active coronary artery disease requiring antianginal therapy

• No active thrombophlebitis

Pulmonary:

• No history of pulmonary embolus

Other:

• No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior biologic therapy and recovered

• No concurrent biologic therapy

Chemotherapy:

• No prior cytotoxic chemotherapy

• No other concurrent chemotherapy

Endocrine therapy:

• Prior androgen-blockade therapy (e.g., luteinizing hormone-releasing hormone agonist and antiandrogen therapy) allowed if administered for a duration of less than 30 days

• Prior neoadjuvant hormonal therapy allowed

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered

• No concurrent radiotherapy

Surgery:

• At least 4 weeks since prior surgery and recovered

Other:

• No concurrent bisphosphonates