Phase I study of docetaxel and irinotecan in patients with advanced non-small-cell lung cancer

Naoyuki Nogami, Shingo Harita, Hiroshi Ueoka, Toshiro Yonei, Katsuyuki Kiura, Haruhito Kamei, Masahiro Tabata, Yoshihiko Segawa, Kenichi Gemba, Mitsune Tanimoto

Research output: Contribution to journalArticle

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Abstract

The role of non-platinum combination chemotherapy in the treatment of advanced non-small-cell lung cancer (NSCLC) has not yet been clarified. In this phase I study, the dose-limiting toxicity (DLT), the maximum tolerable dose (MTD) and the antitumor activity of a two-drug combination of docetaxel (DCT) and irinotecan (CPT) in patients with advanced NSCLC were evaluated. Previously untreated patients with NSCLC in stage IIIB with malignant pleural effusion or stage IV were eligible. Both drugs were administered by 1-h intravenous infusion on day 1, and repeated every 3 weeks. DCT was given before CPT administration. Five escalating dose levels of DCT/CPT (40/135, 50/135, 50/150, 60/150, and 60/165 mg/m2) were studied. Eighteen patients received 44 courses. The DLT was considered to be neutropenia, because grade 4 neutropenia lasting for 3 days or more was observed in three patients, which was accompanied with three episodes of febrile neutropenia. As a non-hematological toxicity, grade 3 diarrhea occurred in three patients. Since all the three patients treated at the fifth dose level (DCT at 60 mg/m2 and CPT at 165 mg/m2) experienced DLT (grade 4 neutropenia in two patients and grade 3 hepatic toxicity in one), this dose level was determined to be the MTD. The objective response rate was 33.3%, and the median survival time was 13.6 months. To confirm the effectiveness of this combination for advanced NSCLC which was suggested in the present study, a phase II study with the recommended doses (150 mg/m2 for CPT and 50-60 mg/m2 for DCT) is warranted.

Original languageEnglish
Pages (from-to)85-91
Number of pages7
JournalLung Cancer
Volume45
Issue number1
DOIs
Publication statusPublished - Jul 2004

Fingerprint

irinotecan
docetaxel
Non-Small Cell Lung Carcinoma
Neutropenia
Malignant Pleural Effusion
Febrile Neutropenia
Drug Combinations
Combination Drug Therapy
Intravenous Infusions

Keywords

  • Docetaxel
  • Irinotecan
  • Non-platinum regimen
  • Non-small-cell lung cancer

ASJC Scopus subject areas

  • Oncology

Cite this

Phase I study of docetaxel and irinotecan in patients with advanced non-small-cell lung cancer. / Nogami, Naoyuki; Harita, Shingo; Ueoka, Hiroshi; Yonei, Toshiro; Kiura, Katsuyuki; Kamei, Haruhito; Tabata, Masahiro; Segawa, Yoshihiko; Gemba, Kenichi; Tanimoto, Mitsune.

In: Lung Cancer, Vol. 45, No. 1, 07.2004, p. 85-91.

Research output: Contribution to journalArticle

Nogami, N, Harita, S, Ueoka, H, Yonei, T, Kiura, K, Kamei, H, Tabata, M, Segawa, Y, Gemba, K & Tanimoto, M 2004, 'Phase I study of docetaxel and irinotecan in patients with advanced non-small-cell lung cancer', Lung Cancer, vol. 45, no. 1, pp. 85-91. https://doi.org/10.1016/j.lungcan.2003.12.008
Nogami, Naoyuki ; Harita, Shingo ; Ueoka, Hiroshi ; Yonei, Toshiro ; Kiura, Katsuyuki ; Kamei, Haruhito ; Tabata, Masahiro ; Segawa, Yoshihiko ; Gemba, Kenichi ; Tanimoto, Mitsune. / Phase I study of docetaxel and irinotecan in patients with advanced non-small-cell lung cancer. In: Lung Cancer. 2004 ; Vol. 45, No. 1. pp. 85-91.
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