Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Carboplatin; Paclitaxel
Intervention description: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle; 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Castrate Resistant Prostate Cancer; CRPC

Summary:

      The purpose of this study is to look at the clinical benefit of carboplatin and paclitaxel
      and correlate response to study treatment with biologic parameters (i.e. lab studies of
      blood, urine, or tissue). It is hoped that this will allow researchers to gain insight into
      the underlying biology of prostate tumor progression and perhaps predict which patients may
      benefit from this chemotherapy regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic diagnosis of prostate carcinoma.

          -  Subject must have progressive metastatic prostate cancer despite adequate medical or
             surgical castration therapy. Furthermore, if applicable, medical castration must be
             maintained for the duration of the protocol.

          -  Serum testosterone < 50 ng/ml.

          -  Subjects who have received anti-androgen therapy with a resulting PSA decline must
             demonstrate progression following discontinuation of anti-androgen therapy.

          -  Subjects capable of fathering children must agree to use an effective method of
             contraception for the duration of the trial.

          -  Must have previously received docetaxel for prostate cancer

          -  ECOG performance status 0-2

          -  Willing and able to give informed consent

        Exclusion Criteria:

          -  Platelet count <100,000/mm3

          -  Absolute neutrophil count (ANC) <1,500/mm3

          -  Hemoglobin < 8 g/dL

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x upper limit
             of normal

          -  Bilirubin (total) >2 x upper limit of normal. Subjects with known Gilbert's syndrome
             are eligible if direct bilirubin is within normal limits

          -  For subjects with serum creatinine > 1.5 x ULN, calculated creatinine clearance < 30
             ml/min are excluded; subjects meeting this exclusion criterion are eligible if a
             measured clearance is > 30 ml/min

          -  Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or
             hematological organ systems which might preclude completion of this study or interfere
             with determination of causality of any adverse effects experienced in this study

          -  Prior investigational therapy within 4 weeks of treatment. Furthermore, other
             investigational anti-cancer therapy is not permitted during the treatment phase.

          -  Grade > 1 peripheral neuropathy