S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: bicalutamide; estramustine; etoposide; flutamide; goserelin; leuprolide; nilutamide; paclitaxel
Intervention MeSH terms: Paclitaxel; Etoposide; Leuprolide; Goserelin; Bicalutamide; Flutamide; Estramustine; Nilutamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage IV prostate cancer; recurrent 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, 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.
    

Eligibility 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