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Phase I/II study of gemcitabine as a fixed dose rate infusion and S-1 combination therapy (FGS) in gemcitabine-refractory pancreatic cancer patients

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Abstract

Purpose

There is no standard regimen for gemcitabine (Gem)-refractory pancreatic cancer (PC) patients. In a previous phase II trial, S-1 was found to exhibit marginal efficacy. Gem administration by fixed dose rate infusion of 10 mg/m2/min (FDR-Gem) should maximize the rate of intracellular accumulation of gemcitabine triphosphate and might improve clinical efficacy. We conducted the phase I/II of FDR-Gem and S-1 (FGS) in patients with Gem-refractory PC.

Methods

The patients received FDR-Gem on day 1 and S-1 orally twice daily on days 1–7. Cycles were repeated every 14 days. Patients were scheduled to receive Gem (mg/m2/week) and S-1 (mg/m2/day) at four dose levels in the phase I: 800/80 (level 1), 1,000/80 (level 2), 1,200/80 (level 3) and 1,200/100 (level 4). Forty patients were enrolled in the phase II study at recommended dose.

Results

The recommended dose was the level 3. In the phase II, a partial response has been confirmed in seven patients (18%). The median overall survival time and median progression-free survival time are 7.0 and 2.8 months, respectively. The common adverse reactions were anorexia, leukocytopenia and neutropenia.

Conclusion

This combination regimen of FGS is active and well tolerated in patients with Gem-refractory PC.

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Author information

Authors and Affiliations

  1. Division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

    Chigusa Morizane, Takuji Okusaka, Hideki Ueno, Shunsuke Kondo & Tomohiro Yamaguchi

  2. Division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, East, Kashiwa, Japan

    Masafumi Ikeda, Kohei Nakachi, Shuichi Mitsunaga & Yasushi Kojima

  3. Division of Medical Oncology, Kyorin University School of Medicine, Tokyo, Japan

    Junji Furuse & Eiichiro Suzuki

  4. Division of Hepatobiliary and Pancreatic Oncology, Kanagawa Cancer Center, Yokohama, Japan

    Ohkawa Shinichi & Makoto Ueno

Authors
  1. Chigusa Morizane
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  2. Takuji Okusaka
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  3. Hideki Ueno
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  4. Shunsuke Kondo
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  5. Masafumi Ikeda
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  6. Junji Furuse
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  7. Ohkawa Shinichi
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  8. Kohei Nakachi
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  9. Shuichi Mitsunaga
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  10. Yasushi Kojima
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  11. Eiichiro Suzuki
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  12. Makoto Ueno
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  13. Tomohiro Yamaguchi
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Corresponding author

Correspondence to Chigusa Morizane.

Additional information

The registration number of this clinical trial is UMIN ID, C000000450.

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Morizane, C., Okusaka, T., Ueno, H. et al. Phase I/II study of gemcitabine as a fixed dose rate infusion and S-1 combination therapy (FGS) in gemcitabine-refractory pancreatic cancer patients. Cancer Chemother Pharmacol 69, 957–964 (2012). https://doi.org/10.1007/s00280-011-1786-6

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  • DOI: https://doi.org/10.1007/s00280-011-1786-6

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