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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients locally advanced, metastatic, or recurrent transitional cell carcinoma of the urothelium.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Achieve Life Sciences; OncoGenex Technologies
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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