Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: carboplatin; estramustine; paclitaxel; radiation therapy; leuprolide or goserelin acetate
Intervention description: AUC=6 week one of each 4 week cycle; 2 tablets tid PO 5 of 7 days per week each 4 week cycle; 80 mg/sq m IV infusion over 1 hour weekly for ea 4 week cycle; 77.4 Gy in 1.8 Gy fractions; 7.5 mg IM injection once every 4 weeks for 6 months
Intervention MeSH terms: Paclitaxel; Carboplatin; Leuprolide; Goserelin; Estramustine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage III 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.
    

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