TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium

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