title: Phase I study of paclitaxel and oral etoposide in previously untreated non-small-cell and extensive small-cell lung cancer.
abstract: OBJECTIVE
  This phase I study of paclitaxel and oral etoposide was performed to determine the safety of the combination in patients with advanced lung cancer who had received no prior chemotherapy, and to identify a dose for phase II testing.
  
  
  METHODS
  Patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) or extensive small-cell lung cancer (SCLC), who had received no prior chemotherapy were treated with intravenous paclitaxel given as a three hour infusion (starting dose 100 mg/m2) and oral etoposide, 100 mg daily for five days. Two schedules of administration were used with the paclitaxel given on day 1 (schedule A) or day 5 (schedule B) of a 21 day cycle.
  
  
  RESULTS
  Forty-nine patients were entered on the study, four of whom had SCLC. All patients were evaluable for toxicity. The maximum tolerated dose was paclitaxel 200 mg/m2 on day 1, in combination with oral etoposide 100 mg daily on days 1 to 5 (schedule A). The dose limiting toxicities were mucositis, myalgia, diarrhoea, and paraesthesiae. Using schedule B, myelosuppression, with febrile neutropenia was dose limiting at a paclitaxel dose of 160 mg/m2. Amongst the 45 patients with NSCLC there were three complete and eight partial responses (24%; 95% CI 13% 40%), while there was one complete response in the four patients with SCLC.
  
  
  CONCLUSIONS
  Paclitaxel 200 mg/m2 on day 1, with oral etoposide 100 mg daily on days 1 to 5 can be administered safely, and is the recommended dose for phase II studies.
authors.affiliation: Royal Prince Alfred Hospital, Sydney, Australia.
authors.forename: M J
authors.initials: MJ
authors.lastname: Boyer
authors.forename: J
authors.initials: J
authors.lastname: Zalcberg
authors.forename: I N
authors.initials: IN
authors.lastname: Olver
authors.forename: M J
authors.initials: MJ
authors.lastname: Millward
authors.forename: G
authors.initials: G
authors.lastname: Richardson
authors.forename: M J
authors.initials: MJ
authors.lastname: McKeage
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage
chemical_list: D005047:Etoposide; D017239:Paclitaxel