Phase I/II trial of docetaxel and carboplatin as a first-line therapy in patients with stage IV non-small-cell lung cancer

Kensuke Kataoka, Ryujiro Suzuki, Hiroyuki Taniguchi, Yasunobu Noda, Joe Shindoh, Syuichi Matsumoto, Yoshiaki Watanabe, Kousuke Honda, Kiyoshi Suzuki, Kenji Baba, Kazuyoshi Imaizumi, Hiroaki Kume, Yoshinori Hasegawa, Kenzo Takagi

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

A phase I/II study was conducted to determine the maximum-tolerated dose, the safety and tolerability, and the clinical efficacy of carboplatin and docetaxel in combination in patients with stage IV non-small-cell lung cancer. Patients with measurable, previously untreated, good performance status, and stage IV non-small-cell lung cancer were eligible. Increasing doses of docetaxel were given in combination with a fixed dose of carboplatin except at level 5. Cycles were repeated every four weeks. Seventy-seven patients were registered. In phase I, 27 patients were entered at five different dose levels. A docetaxel dose of 60 mg/m2 and carboplatin area under the concentration time curve 6 was recommended for phase II, and an additional 50 patients were entered at this level for a total of 56 patients. Grade 3/4 neutropenia was the most common adverse event and occurred in 70% of the patients. Two patients had febrile neutropenia. Fifty-six patients were assessable for response; 21 partial responses were observed for an overall response rate of 37.5%. The median time to tumor progression was 4.0 months (range, 1.0-21.0 months), and the median survival was 12.9 months (range, 0.4-51.3 months). The one-year survival rate was 46.4%. The combination of docetaxel 60 mg/m2 and carboplatin area under the concentration time curve 6 is feasible and effective in patients with stage IV non-small-cell lung cancer.

Original languageEnglish
Pages (from-to)133-139
Number of pages7
JournalLung
Volume184
Issue number3
DOIs
Publication statusPublished - 01-06-2006
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Pulmonary and Respiratory Medicine

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