title: Phase I trial of outpatient weekly paclitaxel and concurrent radiation therapy for advanced non-small-cell lung cancer.
abstract: OBJECTIVE
  To determine the maximum-tolerated dose (MTD) and dose-limiting toxicities of paclitaxel administered weekly on an outpatient basis with concurrent thoracic radiation to patients with advanced non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  In this phase I clinical trial, paclitaxel was administered as a 3-hour intravenous (IV) infusion, repeated every week for 6 weeks. The starting dose of paclitaxel was 10 mg/m2. Doses were escalated at 10-mg/m2 increments in successive cohorts of three new patients if tolerated. Unacceptable toxicity was defined as grade 3 nonhematologic toxicity, excluding nausea and vomiting, and grade 4 hematologic toxicity according to Cancer and Leukemia Group B expanded common toxicity criteria. Radiation was administered to the primary tumor and regional lymph nodes (40 Gy) followed by a boost to the tumor (20 Gy).
  
  
  RESULTS
  Twenty-seven patients were entered onto this study through seven dose escalations (from 10 mg/m2/wk to 70 mg/m2/wk for 6 weeks). Severe esophagitis occurred at 70 mg/m2 (two patients with grade 4 disease and one patient with grade 2). One of six patients at 60 mg/m2 developed grade 3 esophagitis and three of seven patients had grade 2 esophagitis. One of 27 patients developed a hypersensitivity reaction. One of 27 patients developed grade 3 neutropenia.
  
  
  CONCLUSIONS
  Esophagitis is the principle dose-limiting toxicity of weekly paclitaxel and thoracic radiation in the outpatient setting. A phase II trial using concurrent radiation and paclitaxel at the MTD of 60 mg/m2/wk is underway.
authors.affiliation: Department of Radiation Therapy, Rhode Island Hospital, Providence 02903.
authors.forename: H
authors.initials: H
authors.lastname: Choy
authors.forename: W
authors.initials: W
authors.lastname: Akerley
authors.forename: H
authors.initials: H
authors.lastname: Safran
authors.forename: J
authors.initials: J
authors.lastname: Clark
authors.forename: V
authors.initials: V
authors.lastname: Rege
authors.forename: A
authors.initials: A
authors.lastname: Papa
authors.forename: M
authors.initials: M
authors.lastname: Glantz
authors.forename: Y
authors.initials: Y
authors.lastname: Puthawala
authors.forename: C
authors.initials: C
authors.lastname: Soderberg
authors.forename: L
authors.initials: L
authors.lastname: Leone
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004342:Drug Hypersensitivity / Q000209:etiology; D004941:Esophagitis / Q000139:chemically induced; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D011879:Radiotherapy Dosage
chemical_list: D017239:Paclitaxel