A Phase II study of oxaliplatin in urothelial cancer.
OBJECTIVE
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).


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/m2 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.
Winquist
Eric
E
Princess Margaret Hospital Phase II Consortium, London Regional Cancer Centre, London, Ontario, Canada. eric.winquist@lrcc.on.ca
Vokes
Everett
E
Moore
Malcolm J
MJ
Schumm
L Philip
LP
Hoving
Kristin
K
Stadler
Walter M
WM
D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000494:pharmacology; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077150:Oxaliplatin; D016019:Survival Analysis; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002945:Cisplatin