Fractionated administration of irinotecan and cisplatin for treatment of lung cancer: A phase I study

H. Ueoka, M. Tabata, K. Kiura, T. Shibayama, K. Gemba, Y. Segawa, K. Chikamori, T. Yonei, S. Hiraki, M. Harada

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20 Citations (Scopus)


A combination chemotherapy of irinotecan (CPT-11) and cisplatin (CDDP) has been reported to be active for lung cancer. In the previous trial, however, diarrhoea and leucopenia became the major obstacle for sufficient dose escalation of CPT-11 to improve the treatment outcome. We conducted a phase I study to investigate whether the fractionated administration of CDDP and CPT-11 at escalated dose was feasible and could improve the treatment outcome. Twenty-four previously untreated patients with unresectable non-small-cell lung cancer (NSCLC) or extensive disease of small-cell lung cancer (SCLC) were eligible. Both CDDP and CPT-11 were given on days 1 and 8, and repeated every 4 weeks. The dose of CDDP was fixed at 60 mg m-2 and given by 1-h infusion before CPT-11 administration. The starting dose of CPT-11 was 40 mg m-2, and the dose was escalated by an increase of 10 mg m-2. The maximally tolerated dose of CPT-11 was determined as 60 mg m-2 because grade 4 haematological or grade 3 or 4 non-haematological toxicities developed in six patients out of 11 patients evaluated. Diarrhoea became a dose-limiting toxicity. The objective response rates were 76% for NSCLC and 100% for SCLC. The recommended dose of CPT-11 and CDDP in a phase II study will be 50 mg m-2 and 60 mg m-2 respectively.

Original languageEnglish
Pages (from-to)984-990
Number of pages7
JournalBritish Journal of Cancer
Issue number5-6
Publication statusPublished - 1999


  • Cisplatin
  • Irinotecan
  • Non-small-cell lung cancer
  • Phase I study
  • Small-cell lung cancer

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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