Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: carboplatin; paclitaxel
Intervention description: Administered Day 1 of each cycle. AUC=6.; administered Days 1, 8, and 15 of each cycle. 100mg/m2
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer; stage IV 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 may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel with carboplatin
      in treating patients who have metastatic prostate cancer that has not responded to hormone
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be informed of investigational nature of the study and written informed
             consent must be obtained prior to study entry

          -  Patients >18 years of age

          -  Patients with a histologic diagnosis of adenocarcinoma of the prostate

          -  Patients must have metastatic disease with progression despite androgen ablation.
             Patients who have not undergone orchiectomy must continue LHRH analogues. For patients
             receiving LHRH analogues their testosterone level must be < 50ng/dL

          -  Patients with bidimensionally measurable disease or bone metastases that is not
             progressive but who have a rising PSA are eligible

          -  Patients with an ECOG performance status <2

          -  Patients must have discontinued flutamide or nilutamide at least 4 weeks prior to the
             first day of treatment with evidence of progressive disease. Patients must have
             discontinued bicalutamide at least 6 weeks prior to registration with evidence of
             progressive disease

          -  Patients with adequate hematological, renal, and hepatic function as defined by the
             following required laboratory values:

               -  While blood cell count: > 3,000/mm3

               -  Absolute granulocyte count: > 1,500/mm3

               -  Platelets: > 100,000/mm3

               -  Hemoglobin: > 8.5 g/dL

               -  Total bilirubin: < 1.5 mg/dL

               -  Serum creatinine: < 2.5 mg/dL

               -  AST or ALT: < 2.5 x institutional upper limit of normal

          -  Patients may have received prior radiation therapy, provided at least 4 weeks have
             elapsed since the conclusion of radiation therapy

        Exclusion Criteria:

          -  Patients with biochemical only progression

          -  Patients who have received any prior chemotherapy for cancer of the prostate

          -  Patients who received antiandrogen therapy within 4 weeks prior to the first day of
             treatment after cessation of flutamide or nilutamide, and or within 6 weeks prior to
             registration after cessation of bicalutamide

          -  Patients receiving concomitant chemotherapy, biologic therapy, or radiation therapy

          -  Patients who have received Strontium 89 or other radioisotope therapies

          -  Patients with decreasing PSA levels following antiandrogen withdrawal

          -  Patients with > grade 1 peripheral sensory or motor neuropathy

          -  Patients with known carcinomatous meningitis or brain metastases are excluded

          -  Patients with past or current histories of neoplasm other than entry diagnosis except
             for in-situ carcinoma of any site, non-melanoma skin cancer, or other malignancy
             treated by surgery or radiation with a disease-free survival longer than 5 years

          -  Patients who have undergone major surgery < 3 weeks prior to registration, except for
             biopsy or placement of a venous access device. Patients must have fully recovered from
             all effects of any prior surgery

          -  Patients with histories of serious cardiac disease not adequately controlled:
             documented myocardial infarction within the last 6 months preceding registration,
             congestive heart failure, unstable angina, valvular disease with documented
             ventricular compromise, uncontrolled hypertension, arrhythmia uncontrolled by
             medication, clinically significant pericardial effusion

          -  Patients with active serious infections or other serious underlying medical conditions
             that would otherwise impair their ability to receive protocol treatments

          -  Patients with dementia or significantly altered mental status that would prohibit the
             understanding and/or giving of informed consent

          -  Patients receiving other investigational therapy

          -  Use of any investigational agent within 30 days of first day of treatment and use of
             Ketoconazole, hydrocortisone, glucocorticoids, or megace within 30 days of first day
             of treatment or other concomitant medications