title: Phase II trial of carboplatin and paclitaxel in cisplatin-pretreated advanced transitional cell carcinoma: a Southwest Oncology Group study.
abstract: BACKGROUND
  The purpose of the study was to assess the efficacy and toxicity of carboplatin and paclitaxel administered every 3 weeks in patients with advanced urothelial carcinoma, previously treated with cisplatin-based therapy.
  
  
  METHODS
  Eligibility included metastatic or locally advanced unresectable transitional cell carcinoma of the urothelial tract. Prior chemotherapy, except taxanes, was permitted within 12 months. Adequate hematologic, hepatic, and renal function and a performance status of 0-2 were required. Treatment consisted of paclitaxel 200 mg/m2 intravenously for 3 hours followed by carboplatin, target area under the curve = 5 repeated every 3 weeks.
  
  
  RESULTS
  Forty-four patients were enrolled. Thirty-four (77%) patients had a performance status of 0 or 1. Twenty-five (57%) of the patients had received prior neoadjuvant or adjuvant chemotherapy, and 19 (43%) had received it for metastatic disease. In all, 181 cycles were administered (median, 3.5 cycles; range, 1-11 cycles). The predominant NCI CTC (version 2.0) Grades 3 and 4 toxicities consisted of myelosuppression in 28 patients and neuropathy in 11 patients. There were no treatment-related deaths. Of the 44 patients, 1 (2%) had a complete response, 2 (5%) had a partial response, and 4 (9%) had an unconfirmed partial response, for an overall response rate of 16% (95% confidence interval [CI] 7-30%). The median progression-free survival was 4 months (95% CI 3-5 months) and the median survival was 6 months (95% CI 5-8 months).
  
  
  CONCLUSIONS
  Carboplatin and paclitaxel combination is well tolerated and has modest activity in platinum refractory advanced urothelial carcinoma. Effective regimens need to be developed in cisplatin-pretreated urothelial carcinoma.
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, Wayne State University Medical Center, Detroit, Michigan 48201, USA. vaishamu@karmanos.org
authors.forename: Ulka N
authors.initials: UN
authors.lastname: Vaishampayan
authors.forename: James R
authors.initials: JR
authors.lastname: Faulkner
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Small
authors.forename: Bruce G
authors.initials: BG
authors.lastname: Redman
authors.forename: Wayne L
authors.initials: WL
authors.lastname: Keiser
authors.forename: Daniel P
authors.initials: DP
authors.lastname: Petrylak
authors.forename: E David
authors.initials: ED
authors.lastname: Crawford
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D016879:Salvage Therapy; D015996:Survival Rate; D014571:Urologic Neoplasms / Q000188:drug therapy*
chemical_list: D016190:Carboplatin; D017239:Paclitaxel; D002945:Cisplatin