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

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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.

Conclusion

These results indicate that this triplet chemotherapy is feasible and effective in patients with advanced NSCLC.

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Authors and Affiliations

  1. Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan

    Masahiro Tabata & Nagio Takigawa

  2. Department of Hematology, Oncology, and Respiratory Medicine (Internal Medicine II), Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan

    Toshiyuki Kozuki, Katsuyuki Kiura & Mitsune Tanimoto

  3. Department of Internal Medicine, National Hospital Organization Sanyo Hospital, 685 Higashi-Kiwa, Ube Yamaguchi, 755-0241, Japan

    Hiroshi Ueoka & Daizo Kishino

  4. Department of Internal Medicine, Chugoku Central Hospital, Fukuyama, Japan

    Shingo Harita

  5. Department of Respiratory Medicine, National Hospital Organization Minami-Okayama Medical Center, Okayama, Japan

    Atsuhiko Tada & Takuo Shibayama

  6. Department of Respiratory Medicine, National Hospital Organization Okayama Medical Center, Okayama, Japan

    Toshiro Yonei

  7. Department of Respiratory Medicine, Okayama Rosai Hospital, Okayama, Japan

    Kenichi Gemba

  8. Department of Respiratory Medicine, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan

    Yoshihiko Segawa

  9. Department of Internal Medicine, Kagawa Rosai Hospital, Kagawa, Japan

    Shinya Tada

  10. Department of Internal Medicine, Okayama Red Cross Hospital, Okayama, Japan

    Shunkichi Hiraki

Authors
  1. Masahiro Tabata
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  2. Toshiyuki Kozuki
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  3. Hiroshi Ueoka
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  4. Katsuyuki Kiura
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  9. Toshiro Yonei
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  10. Kenichi Gemba
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  11. Yoshihiko Segawa
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  13. Shinya Tada
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  14. Shunkichi Hiraki
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  15. Mitsune Tanimoto
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for the Okayama Lung Cancer Study Group

Corresponding author

Correspondence to Hiroshi Ueoka.

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Tabata, M., Kozuki, T., Ueoka, H. et al. A triplet chemotherapy with cisplatin, docetaxel and gemcitabine in patients with advanced non-small-cell lung cancer: a phase I/II study. Cancer Chemother Pharmacol 60, 53–59 (2007). https://doi.org/10.1007/s00280-006-0346-y

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  • DOI: https://doi.org/10.1007/s00280-006-0346-y

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