Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer

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