title: Phase II study of a one hour paclitaxel infusion in combination with carboplatin for advanced non-small cell lung cancer.
abstract: OBJECTIVE
  To determine the activity, toxicity, and optimal dose of paclitaxel when given by one hour infusion combined with carboplatin in advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Thirty-seven previously untreated patients with stage IIIB or IV NSCLC were enrolled. Paclitaxel was administered by one hour infusion at a dose of 175 mg/m2 for the first cycle, and was escalated up to 255 mg/m2 over successive cycles if tolerated. In the absence of toxicity, the carboplatin dose was kept constant at an area under the concentration-time curve (AUC) of 6. Cycles were repeated at 3-week intervals until progression or intolerable toxicity occurred.
  
  
  RESULTS
  Thirty-six patients were evaluable for toxicity and survival, and thirty-five for responses. The partial response rate was 10 of 35 (29%) and there were no complete responses. The median duration of response was 4.8 months (range 0.5-11.7 months). The median survival duration was 6.5 months, and 1 year survival was 31%. The mean paclitaxel dose was 188 mg/m2. Treatment was generally well tolerated. Four patients (11%) had febrile neutropenia. Five patients (14%) had grade 3 neuropathy, and 4 (11%) had grade 3 nausea and vomiting. Minor toxicities included alopecia, myalgias, arthralgias and stomatitis.
  
  
  CONCLUSIONS
  Paclitaxel and carboplatin is a well-tolerated regimen that can safely be given by a one hour paclitaxel infusion. The modest response rate observed in this study may be due to either the low dose-intensity of paclitaxel or the short infusion duration. Further trials to optimize the relative doses of paclitaxel and carboplatin are needed.
authors.affiliation: Ottawa Regional Cancer Centre, University of Ottawa, Ontario Cancer Treatment and Research Foundation, Canada.
authors.forename: W K
authors.initials: WK
authors.lastname: Evans
authors.forename: C C
authors.initials: CC
authors.lastname: Earle
authors.forename: D J
authors.initials: DJ
authors.lastname: Stewart
authors.forename: S
authors.initials: S
authors.lastname: Dahrouge
authors.forename: E
authors.initials: E
authors.lastname: Tomiak
authors.forename: G
authors.initials: G
authors.lastname: Goss
authors.forename: D
authors.initials: D
authors.lastname: Logan
authors.forename: R
authors.initials: R
authors.lastname: Goel
authors.forename: S Z
authors.initials: SZ
authors.lastname: Gertler
authors.forename: H
authors.initials: H
authors.lastname: Dulude
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage
chemical_list: D016190:Carboplatin; D017239:Paclitaxel