A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Taxane-Resistant Androgen-Independent Metastatic Prostate Cancer

Pts must have hist dx of adeno of the prostate which is metastatic (N1 and/or M1) and deemed unresponsive or refractory to androgen deprivation therapy. Pts must have rec'd 1 prior taxane-containing chemo regimen for met dz at least 28 days prior to reg and dc'd chemo due to progression, intolerance, or pt request. Pt must have current evidence of dz prog per 5.2 of protocol. Pts must have pre-study PSA > 5 ng/ml w/in 28 days prior to reg. Measurable dz must be assessed w/in 28 days, and non-measurable w/in 42 days. Pts must have had a CT or MRI of the abd/pelvis w/in 28 days and bone scan w/in 42 days. Pt must have been surgically or medically castrated. If by LHRH agonists or antagonist, pt must be willing to cont/restart. If pt has been tx'd w/non-steroidal antiandrogens or other hormonal tx, tx must have been stopped per 5.7. Prior RT allowed, but 28 days must have elapsed. Pts may have rec'd prior surgery, but 21 days must have elapsed. Pt must have available and be willing to submit archival tumor tissue for molecular correlatives outlined in 15.2. Pts must be willing to submit blood for PK and for isolation of PBMC. Site must order S0418 PK Kit immediately after registration (see 19.1). Pts must have AGC >/= 1,500, HGB >/= 9 mg/dl, PLT >/= 100,000, Bili w/in IULN, SGOT and SGPT </= 2.5 IULN, creat </= 1.5 x IULN or cal CrCL >/= 40 mL/min for pts w/creat levels above inst. normal w/in 14 days prior to reg. Pts must have a Zubrod PS of 0-2. Pts with hx of brain mets or who currently have treated or untreated brain mets are not eligible. Pts w/clinical suspicion of brain mets must have a brain CT or MRI negative for met dz obtained w/in 56 days prior to reg and must not have any new symptoms since radiographic eval was done. Pts with peripheral neuropathy >/= Grade 2 are not eligible. Pts must not be planning to receive other anti-cancer therapy while on study. SB-715992 is a moderate to significant in vitro inhibitor of CYP3A4, therefore medications are prohibited as outlined in Section 5.20. Pts must not have a hx of allergic reactions attributed to compounds of similar chemical or biologic composition to SB-715992. Pts must not have any uncontrolled intercurrent illness that would limit compliance. Pts rec'g combo anti-retroviral therapy are not eligible.