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
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