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Clinical Trial
. 2009 Mar;135(3):365-70.
doi: 10.1007/s00432-008-0480-5. Epub 2008 Oct 31.

A phase I study of combination therapy with S-1 and irinotecan (CPT-11) in patients with advanced colorectal cancer

Manabu Shiozawa  1 , Nobuhiro Sugano, Kazuhito Tsuchida, Soichiro Morinaga, Makoto Akaike, Yukio Sugimasa
Affiliations
Clinical Trial

A phase I study of combination therapy with S-1 and irinotecan (CPT-11) in patients with advanced colorectal cancer

Manabu Shiozawa et al. J Cancer Res Clin Oncol. 2009 Mar.

Abstract

Purpose: The aim of this study was to determine the maximum tolerated dose, recommended dose and dose-limiting toxicities of irinotecan (CPT-11) plus S-1 in advanced colorectal cancer.

Methods: S-1 was administered orally at 80 mg/m(2) per day for 14 consecutive days followed by a 2-week rest. CPT-11 was given intravenously on days 1 and 15 of each course, at an initial dose of 80 mg/m(2) per day, stepping up to 100, 120 or 150 mg/m(2) per day. Courses were repeated every 4 weeks, unless disease progression or severe toxicities were observed.

Results: A total of 21 patients were entered in this study. The maximum tolerated dose of CPT-11 was considered to be 150 mg/m(2), because 2 of 3 patients developed dose-limiting toxicities such as leukopenia, neutropenia, diarrhea and anorexia. The recommend dose of CPT-11 was set at 120 mg/m(2). Tumor response rate was 42.8% and median progression-free survival time was 10 months (95% confidential interval, 6.0-14.0 months).

Conclusion: A combination of S-1 and CPT-11 showed a good safety profile and can be recommended for further phase II studies in patients with colorectal cancer.

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Fig. 1
Progression-free survival rate
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References

    1. Bajetta E, Di Bartolomeo M, Mariani L, Cassata A, Artale S, Frustaci S et al (2003) Randomized multicenter phase II trial of two different schedules of irinotecan combined with capecitabine as first-line treatment in metastatic colorectal carcinoma. Cancer 100:279–287. doi:10.1002/cncr.11910 - PubMed
    1. Bajetta E, Di Bartolomeo M, Buzzoni R, Mariani L, Zilembo N, Ferrario E et al (2007) Uracil/ftorafur/leucovorin combined with irinotecan (TEGAFIRI) or oxaliplatin (TEGAFOX) as first-line treatment for metastatic colorectal cancer patients: results of randomized phase II study. Br J Cancer 96:439–444. doi:10.1038/sj.bjc.6603493 - PMC - PubMed
    1. Borner MM, Bernhard J, Dietrich D, Popescu R, Wernli M, Saletti P et al (2005) A randomized phase II trial of capecitabine and two different schedules of irinotecan in first-line treatment of metastatic colorectal cancer: efficacy, quality-of-life and toxicity. Ann Oncol 16:282–288. doi:10.1093/annonc/mdi047 - PubMed
    1. Colucci G, Gebbia V, Paoletti G, Giuliani F, Caruso M, Gebbia N et al (2005) Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer: multicenter study of the Gruppo Oncologico Dell’italia Meridionale. J Clin Oncol 23:4866–4875. doi:10.1200/JCO.2005.07.113 - PubMed
    1. Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P et al (2000) Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomized trial. Lancet 355:1041–1047. doi:10.1016/S0140-6736(00)02034-1 - PubMed

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