title: Phase I trial of paclitaxel/carboplatin in advanced carcinoma of the urothelium.
abstract: We performed a phase I trial of 3-hour paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) (dose levels of 150, 175, 200, and 225 mg/m2) plus carboplatin dosed to an area under the concentration-time curve of 6. Sixteen patients were treated. Dose-limiting neuropathy was demonstrated in one patient each at the 175 and 200 mg/m2 dose levels. Grade 3 to 4 granulocytopenia was common; grade 3 to 4 thrombocytopenia was uncommon. The maximum tolerated dose of the regimen was not reached. Two complete and seven partial responses were demonstrated. We conclude that paclitaxel 225 mg/m2 plus carboplatin dosed to an area under the concentration-time curve of 6 can be administered to patients with advanced carcinoma of the urothelium. The regimen has encouraging preliminary activity. Phase II accrual is ongoing.
authors.affiliation: University of Pennsylvania Cancer Center/Penn Cancer Clinical Trials Group, Philadelphia 19104, USA.
authors.forename: D J
authors.initials: DJ
authors.lastname: Vaughn
authors.forename: S B
authors.initials: SB
authors.lastname: Malkowicz
authors.forename: B
authors.initials: B
authors.lastname: Zoltick
authors.forename: P
authors.initials: P
authors.lastname: Ramchandani
authors.forename: B
authors.initials: B
authors.lastname: Tonkonow
authors.forename: B
authors.initials: B
authors.lastname: Armstead
authors.forename: A
authors.initials: A
authors.lastname: Wein
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D019540:Area Under Curve; D016190:Carboplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D014571:Urologic Neoplasms / Q000188:drug therapy*; D019459:Urothelium
chemical_list: D016190:Carboplatin; D017239:Paclitaxel