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. 1999 Feb;79(5-6):984–990. doi: 10.1038/sj.bjc.6690157

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

H Ueoka 1, M Tabata 1, K Kiura 1, T Shibayama 1, K Gemba 1, Y Segawa 2, K Chikamori 3, T Yonei 4, S Hiraki 5, M Harada 1
PMCID: PMC2362688  PMID: 10070901

Abstract

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. © 1999 Cancer Research Campaign

Keywords: phase I study, irinotecan, cisplatin, small-cell lung cancer, non-small-cell lung cancer

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Selected References

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