Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: docetaxel; mitoxantrone hydrochloride; conventional surgery
Intervention description: 35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.; Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.; Prostatectomy will be scheduled 2 - 4 weeks after the last dose of chemotherapy.
Intervention MeSH terms: Docetaxel; Mitoxantrone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage II prostate cancer; 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. Combining more than one drug and giving chemotherapy before surgery
      may shrink the tumor so that it can be removed during surgery.

      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by
      surgery in treating patients who have localized prostate cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the prostate

               -  High-risk, as defined by 1 of the following:

                    -  Stage T2b (palpable bilateral involvement) or surgically resectable T3

                    -  PSA 15 ng/mL or greater

                    -  Gleason grade greater than 4+3 (4+3, 4+4, or 5+any, but not 3+4)

          -  At least a 50% chance of prostate cancer recurrence within 5 years

          -  Planned prostatectomy as primary therapy

          -  No evidence of bone metastases by bone scan

          -  No evidence of lymph nodes greater than 2 cm on pelvic computed tomography (CT) scan
             (scan required only if PSA greater than 40 ng/mL)

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Eastern Cooperative Oncology Group(ECOG) 0-2

        Life expectancy:

          -  At least 10 years

        Hematopoietic:

          -  White Blood Cell(WBC) at least 3,000/mm^3

          -  Neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic:

          -  Conjugated bilirubin no greater than upper limit of normal (ULN)

          -  Alkaline phosphatase no greater than 4 times ULN

          -  Alanine transaminase(ALT) no greater than 2 times ULN (1.5 times ULN if alkaline
             phosphatase greater than 2.5 times ULN)

        Renal:

          -  Not specified

        Cardiovascular:

          -  Ejection fraction greater than 50% by Multiple Gated Acquisition(MUGA)scan

        Other:

          -  No other malignancy within the past 5 years except nonmelanoma skin cancer

          -  No significant active medical illness that would preclude study therapy

          -  No peripheral neuropathy grade 2 or greater

          -  No hypersensitivity to drugs formulated with polysorbate-80

          -  No significant contraindications to corticosteroids

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  No prior cytotoxic chemotherapy

          -  No other concurrent cytotoxic chemotherapy

        Endocrine therapy:

          -  No prior or concurrent conventional hormonal therapy

        Radiotherapy:

          -  No prior or concurrent radiotherapy (external beam or brachytherapy)

        Surgery:

          -  See Disease Characteristics

        Other:

          -  No prior or concurrent cryotherapy