Safety and Efficacy of S-8184 in Treatment of Locally Advanced, Metastatic, or Recurrent TCC of the Urothelium

Inclusion Criteria:

* Histologic diagnosis of transitional cell carcinoma of the urothelium including renal pelvis, ureter, bladder, or urethra
* Locally advanced with lymph node disease(unresectable T3-4, N+, M0); metastatic (T any, N any, MI); or locally recurrent disease following initial definitive therapy
* One and only one prior systemic cytotoxic chemotherapy regimen (note that intravesical treatments are not included in the definition of systemic cytotoxic chemotherapy)
* Failure of first line systemic chemotherapy with a platinum-containing combination regimen consisting of MVAC or cisplatin/gemcitabine with cisplatin dosed at 60 mg/m2 or higher per cycle
* Adult (18 years of age or older) patients
* Adequate hematologic function (ANC greater than 1500 cells/mm3 and platelets greater than 100,000/mm3)
* Serum creatinine less than 2.0 mg/dL
* Total bilirubin less than 1.5 mg/dL; SGOT and SGPT less than 3 times the upper limit of institutional normal values
* ECOG performance status of 0 - 2
* Bidimensional measurable disease
* Patients who have signed an IRB / Ethics Committee approved informed consent
* Life expectancy at least 12 weeks
* Patient has fully recovered from any previous surgery (at least 4 weeks since major surgery)
* Patient has a negative pregnancy test prior to study entry if premenopausal. (Patients of child bearing potential must use a medically effective form of contraception during the treatment.)

Exclusion Criteria:

* Patients who have received any taxane-containing preparation including Taxol (paclitaxel) or Taxotere (docetaxel)
* Patients with intracranial metastases
* Females who are pregnant or lactating
* Patients with peripheral neuropathy NCI-CTC grade 2 or greater
* Patients who have received wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of study entry; or mitomycin or nitrosoureas within 6 weeks of study entry
* Patients who have had an investigational agent within 4 weeks of study entry
* Patients receiving concurrent anticonvulsants known to induce P450 isoenzymes