A Phase 2 Multicenter Evaluation of the Safety and Efficacy of TOCOSOL(TM) Paclitaxel (S-8184 Paclitaxel Injectable Emulsion) in Patients With Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma of the Urothelium

Study start date: November 1, 2003

Inclusion Criteria: * Histologic diagnosis of transitional cell carcinoma (TCC) of the urothelium including bladder, renal pelvis, ureter, or urethra * Stage IV disease * One and only one prior systemic cytotoxic chemotherapy regimen administered as adjuvant or neoadjuvant chemotherapy or to treat locally advanced or metastatic disease * Adequate hematologic function (ANC \>/= 1500 cells/mm3 \& platelet count \>/= 100,000/mm3) * Serum creatinine \</= 2.0 mg/dL * Total bilirubin \</= 1.5 mg/dL * SGOT \& SGPT \</= 3 times upper limit of institutional normal values * PT (INR) \& PTT within institutional lab normal range * Karnofsky performance status of 60-100% * At least one unidimensionally measurable lesion, suitable for radiographic evaluation of disease response, consistent with RECIST criteria * Signed IRB/EC approved Informed Consent * Life expectancy of at least 12 weeks * 18 years of age or older * Fully recovered from any previous surgery * Not pregnant and willing to use a medically effective form of contraception during periods of chemotherapy treatment (both males and and females) * Agree not to take vitamin E supplementation while receiving study medication * Willing to participate in requested follow-up evaluations * Willing to permit treating physicians to provide information to Sonus regarding disease status and survival for 2 years after first dose of study drug Exclusion Criteria: * Prior taxane-containing chemotherapy including Taxol(R) (paclitaxel) or generic equivalent, or Taxotere(R) (docetaxel) * Peripheral neuropathy NCI-CTC grade 2 or greater * Wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of first dose, or mitomycin or nitrosoureas within 6 weeks of first dose, of study drug * An investigational agent within 4 weeks of first dose of study drug * Concurrent anticonvulsants known to induce P450 isoenzymes * Patients who are pregnant or lactating * A history of carcinoma of another primary site (other than non-melanoma skin cancers or carcinoma-in-situ of the cervix) within the previous 5 years, unless metastatic disease has been biopsied and documented to be TCC * Bone metastasis, effusions, ascites or elevated tumor markers as the only evidence of metastatic TCC * Brain metastasis * Active bowel obstruction * Active, serious infection or other serious medical problems (other than TCC) likely to impair completion of the study protocol