A Phase II study of oxaliplatin in urothelial cancer

Purpose: To assess the antitumor activity of oxaliplatin, a third generation platinum derivative with a 1,2-diaminocyclohexane (DACH) carrier ligand, in patients with metastatic transitional cell carcinoma of the bladder (TCC). Patients and Methods: In a double-arm two-stage Phase II trial, adult patients with previously treated measurable unresectable or metastatic TCC were stratified as "cisplatin-sensitive" or "cisplatin-resistant" based on timing of prior cisplatin treatment and treated with oxaliplatin 130 mg/m(2) IV every 3 weeks. The primary endpoint was objective response, and secondary endpoints were duration of response, overall survival, and toxicity. Results: Twenty patients were enrolled between February 2000 and February 2002. A median of two treatment cycles (range, 1-6) were administered. One partial response was observed in 10 cisplatin-sensitive patients, and no responses occurred in eight cisplatin-resistant patients. The most common side effects were fatigue, sensory neuropathy, and nausea. Hematological toxicities were Grade 2 or less. Eleven patients (55%) experienced nonhematological toxicity of Grade 3 or 4, and one patient died of pulmonary embolism after the first cycle. Conclusions: Minimal antitumor activity of single-agent oxaliplatin was observed in TCC patients previously treated with chemotherapy regardless of time from prior cisplatin exposure. (c) 2005 Elsevier Inc. All rights reserved.