A triplet chemotherapy with cisplatin, docetaxel and gemcitabine in patients with advanced non-small-cell lung cancer: A phase I/II study

Masahiro Tabata, Toshiyuki Kozuki, Hiroshi Ueoka, Katsuyuki Kiura, Shingo Harita, Atsuhiko Tada, Takuo Shibayama, Nagio Takigawa, Toshiro Yonei, Kenichi Gemba, Yoshihiko Segawa, Daizo Kishino, Shinya Tada, Shunkichi Hiraki, Mitsune Tanimoto

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Purpose: We conducted a phase I/II study of triplet chemotherapy consisting of cisplatin (CDDP), docetaxel (DCT) and gemcitabine (GEM) in patients with advanced non-small-cell lung cancer (NSCLC). Methods: Fifty-three untreated patients with stage IIIB or IV NSCLC were enrolled. All drugs were given on days 1 and 8. The doses of CDDP and DCT were fixed at 40 mg/m2 and 30 mg/m2, respectively. In the phase I portion, a dose escalation study of GEM with starting dose of 400 mg/m2 was conducted and primary objective in the phase II portion was response rate. Results: The maximally tolerated dose (MTD) and recommended dose (RD) of GEM were determined as 800 mg/m2 because grade 3 non-hematological toxicity (liver damage, diarrhea, and fatigue) developed in three of nine patients evaluated at that dose level. In pharmacokinetic analysis, C max and AUC of dFdC and dFdU were increased along with the dose escalation of GEM. However, no relationship between pharmacokinetic parameters and toxicity or response was observed. Objective response rate was 34% and median survival time was 11.7 months. Though major toxicity was myelosuppression, there were no life-threatening toxicities. These results indicate that this triplet chemotherapy is feasible and effective in patients with advanced NSCLC.

Original languageEnglish
Pages (from-to)53-59
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Volume60
Issue number1
DOIs
Publication statusPublished - Jun 2007

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docetaxel
gemcitabine
Chemotherapy
Non-Small Cell Lung Carcinoma
Cisplatin
Toxicity
Cells
Drug Therapy
Pharmacokinetics
Maximum Tolerated Dose
Liver
Area Under Curve
Fatigue
Diarrhea
Fatigue of materials
Survival
Pharmaceutical Preparations

Keywords

  • Cisplatin
  • Docetaxel
  • Gemcitabine
  • Non-small-cell lung cancer
  • Phase I/II study

ASJC Scopus subject areas

  • Cancer Research
  • Pharmacology
  • Oncology

Cite this

A triplet chemotherapy with cisplatin, docetaxel and gemcitabine in patients with advanced non-small-cell lung cancer : A phase I/II study. / Tabata, Masahiro; Kozuki, Toshiyuki; Ueoka, Hiroshi; Kiura, Katsuyuki; Harita, Shingo; Tada, Atsuhiko; Shibayama, Takuo; Takigawa, Nagio; Yonei, Toshiro; Gemba, Kenichi; Segawa, Yoshihiko; Kishino, Daizo; Tada, Shinya; Hiraki, Shunkichi; Tanimoto, Mitsune.

In: Cancer Chemotherapy and Pharmacology, Vol. 60, No. 1, 06.2007, p. 53-59.

Research output: Contribution to journalArticle

Tabata, M, Kozuki, T, Ueoka, H, Kiura, K, Harita, S, Tada, A, Shibayama, T, Takigawa, N, Yonei, T, Gemba, K, Segawa, Y, Kishino, D, Tada, S, Hiraki, S & Tanimoto, M 2007, 'A triplet chemotherapy with cisplatin, docetaxel and gemcitabine in patients with advanced non-small-cell lung cancer: A phase I/II study', Cancer Chemotherapy and Pharmacology, vol. 60, no. 1, pp. 53-59. https://doi.org/10.1007/s00280-006-0346-y
Tabata, Masahiro ; Kozuki, Toshiyuki ; Ueoka, Hiroshi ; Kiura, Katsuyuki ; Harita, Shingo ; Tada, Atsuhiko ; Shibayama, Takuo ; Takigawa, Nagio ; Yonei, Toshiro ; Gemba, Kenichi ; Segawa, Yoshihiko ; Kishino, Daizo ; Tada, Shinya ; Hiraki, Shunkichi ; Tanimoto, Mitsune. / A triplet chemotherapy with cisplatin, docetaxel and gemcitabine in patients with advanced non-small-cell lung cancer : A phase I/II study. In: Cancer Chemotherapy and Pharmacology. 2007 ; Vol. 60, No. 1. pp. 53-59.
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AU - Tabata, Masahiro

AU - Kozuki, Toshiyuki

AU - Ueoka, Hiroshi

AU - Kiura, Katsuyuki

AU - Harita, Shingo

AU - Tada, Atsuhiko

AU - Shibayama, Takuo

AU - Takigawa, Nagio

AU - Yonei, Toshiro

AU - Gemba, Kenichi

AU - Segawa, Yoshihiko

AU - Kishino, Daizo

AU - Tada, Shinya

AU - Hiraki, Shunkichi

AU - Tanimoto, Mitsune

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N2 - Purpose: We conducted a phase I/II study of triplet chemotherapy consisting of cisplatin (CDDP), docetaxel (DCT) and gemcitabine (GEM) in patients with advanced non-small-cell lung cancer (NSCLC). Methods: Fifty-three untreated patients with stage IIIB or IV NSCLC were enrolled. All drugs were given on days 1 and 8. The doses of CDDP and DCT were fixed at 40 mg/m2 and 30 mg/m2, respectively. In the phase I portion, a dose escalation study of GEM with starting dose of 400 mg/m2 was conducted and primary objective in the phase II portion was response rate. Results: The maximally tolerated dose (MTD) and recommended dose (RD) of GEM were determined as 800 mg/m2 because grade 3 non-hematological toxicity (liver damage, diarrhea, and fatigue) developed in three of nine patients evaluated at that dose level. In pharmacokinetic analysis, C max and AUC of dFdC and dFdU were increased along with the dose escalation of GEM. However, no relationship between pharmacokinetic parameters and toxicity or response was observed. Objective response rate was 34% and median survival time was 11.7 months. Though major toxicity was myelosuppression, there were no life-threatening toxicities. These results indicate that this triplet chemotherapy is feasible and effective in patients with advanced NSCLC.

AB - Purpose: We conducted a phase I/II study of triplet chemotherapy consisting of cisplatin (CDDP), docetaxel (DCT) and gemcitabine (GEM) in patients with advanced non-small-cell lung cancer (NSCLC). Methods: Fifty-three untreated patients with stage IIIB or IV NSCLC were enrolled. All drugs were given on days 1 and 8. The doses of CDDP and DCT were fixed at 40 mg/m2 and 30 mg/m2, respectively. In the phase I portion, a dose escalation study of GEM with starting dose of 400 mg/m2 was conducted and primary objective in the phase II portion was response rate. Results: The maximally tolerated dose (MTD) and recommended dose (RD) of GEM were determined as 800 mg/m2 because grade 3 non-hematological toxicity (liver damage, diarrhea, and fatigue) developed in three of nine patients evaluated at that dose level. In pharmacokinetic analysis, C max and AUC of dFdC and dFdU were increased along with the dose escalation of GEM. However, no relationship between pharmacokinetic parameters and toxicity or response was observed. Objective response rate was 34% and median survival time was 11.7 months. Though major toxicity was myelosuppression, there were no life-threatening toxicities. These results indicate that this triplet chemotherapy is feasible and effective in patients with advanced NSCLC.

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