title: A phase II study of weekly paclitaxel, cisplatin and concurrent radiation therapy for locally-advanced unresectable non-small cell lung cancer: early closure due to lack of efficacy.
abstract: OBJECTIVE
  In this phase II study, the efficacy and safety of weekly paclitaxel concomitant with cisplatin and thoracic radiotherapy (TRT) was evaluated in patients with locally-advanced unresectable non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Patients with stage III NSCLC (without pleural effusion or cervical lymphadenopathy) received TRT (63 Gy in 35 fractions over 7 weeks) with concurrent weekly cisplatin 20 mg/m(2) and paclitaxel 40 mg/m(2)/week infused over 3 hours. In patients without evidence of disease progression, the administration of a further 2 cycles of consolidation chemotherapy, consisting of paclitaxel 175 mg/m(2) and cisplatin 75 mg/m(2), were planned after completion of the TRT.
  
  
  RESULTS
  Between Feb 2000 and Dec 2002, 20 patients were entered into the study; 13 completed all 7 weeks of treatment (median 7.6 weeks; range 3.3 to 9.4). Seven out of 16 (43.8%) objective responses were observed, with 15 (75%) patients experiencing at least one episode of grade 3/4 toxicity. The main toxicities were moderate to severe neutropenia and gastrointestinal toxicity.
  
  
  CONCLUSIONS
  The unsatisfactory response rate and the high incidence of grade 3/4 hematologic and non-hematologic toxicities, including 7 early discontinuations of treatment and exceeding the study stopping rules, prompted the early closure of the study. In view of the activity observed, the protocol was amended to protracted continuous infusion paclitaxel, cisplatin and concurrent TRT.
authors.affiliation: Department of Internal Medicine, Gachon Medical School Gil Medical Center, Incheon, Korea.
authors.forename: Se Hoon
authors.initials: SH
authors.lastname: Park
authors.forename: Mi Kyung
authors.initials: MK
authors.lastname: Kim
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Kyung
authors.forename: Young-Hee
authors.initials: YH
authors.lastname: Lim
authors.forename: Chang Hyeok
authors.initials: CH
authors.lastname: An
authors.forename: Jeong Woong
authors.initials: JW
authors.lastname: Park
authors.forename: Seong Hwan
authors.initials: SH
authors.lastname: Jeong
authors.forename: Jae Woong
authors.initials: JW
authors.lastname: Lee
authors.forename: Kyu Chan
authors.initials: KC
authors.lastname: Lee
authors.forename: Eun Kyung
authors.initials: EK
authors.lastname: Cho
authors.forename: Soo Mee
authors.initials: SM
authors.lastname: Bang
authors.forename: Dong Bok
authors.initials: DB
authors.lastname: Shin
authors.forename: Jae Hoon
authors.initials: JH
authors.lastname: Lee