title: Phase II Clinical Trial of Genexol® (Paclitaxel) and Carboplatin for Patients with Advanced Non-small Cell Lung Cancer.
abstract: OBJECTIVE
  This phase II clinical trial was conducted to evaluate the activity and safety of a combination treatment of paclitaxel (Genexol®) plus carboplatin in patients with advanced non-small cell lung cancer.
  
  
  METHODS
  Chemotherapy-naïve patients having histologically confirmed advanced or metastatic non-small cell lung cancer were enrolled. Genexol® was administered at 225 mg/m(2) intravenous (IV) infusion over 3 hours, followed by carboplatin (area under the concentration-time curve=6) IV on day 1 every 3 weeks.
  
  
  RESULTS
  Twenty-eight patients were enrolled between January 2003 and January 2005. A total of 110 cycles of chemotherapy were given. The median number of chemotherapy cycles was 4. A total of 25 study patients were evaluable. On an intent-to-treat basis, there were ten partial responses (response rate 35.7%). The median time-to-progression was 3.2 months (95% confidence interval [CI], 1.5 to 4.9) and the median overall survival was 8.2 months (95% CI, 4.1 to 12.3). The main hematologic grade 3/4 toxicity was neutropenia, which was observed in 14 (50.0%) patients. The main non-hematologic toxicity was peripheral neuropathy, which was observed in 12 patients (42.9%). Grade 3/4 neuropathy occurred in 8 patients (28.6%) and three patients discontinued treatment because of neuropathy.
  
  
  CONCLUSIONS
  In this trial, the combination of Genexol® and carboplatin showed significant activity as first line treatment for patients with advanced or metastatic non-small cell lung cancer. However, a modest dose reduction of Genexol® is needed due to sensory neuropathy.
authors.affiliation: Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.
authors.forename: Han Jo
authors.initials: HJ
authors.lastname: Kim
authors.forename: Kyoung Ha
authors.initials: KH
authors.lastname: Kim
authors.forename: Jina
authors.initials: J
authors.lastname: Yun
authors.forename: Se Hyung
authors.initials: SH
authors.lastname: Kim
authors.forename: Hyun Jung
authors.initials: HJ
authors.lastname: Kim
authors.forename: Sang-Cheol
authors.initials: SC
authors.lastname: Lee
authors.forename: Sang Byung
authors.initials: SB
authors.lastname: Bae
authors.forename: Chan Kyu
authors.initials: CK
authors.lastname: Kim
authors.forename: Nam Su
authors.initials: NS
authors.lastname: Lee
authors.forename: Kyu Taek
authors.initials: KT
authors.lastname: Lee
authors.forename: Do-Jin
authors.initials: DJ
authors.lastname: Kim
authors.forename: Seong-Kyu
authors.initials: SK
authors.lastname: Park
authors.forename: Jong-Ho
authors.initials: JH
authors.lastname: Won
authors.forename: Dae Sik
authors.initials: DS
authors.lastname: Hong
authors.forename: Hee Sook
authors.initials: HS
authors.lastname: Park