Safety And Efficacy Of Weekly Administration Of S-8184 Paclitaxel Injectable Emulsion In Second Line Treatment Of Patients With Locally Advanced, Metastatic, Or Recurrent Transitional Cell Carcinoma 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