Literature DB >> 17998785

Phase II clinical trial for prevention of delayed diarrhea with cholestyramine/levofloxacin in the second-line treatment with irinotecan biweekly in patients with metastatic colorectal carcinoma.

Dimitri Flieger1, Christine Klassert, Sabine Hainke, Ralf Keller, Rolf Kleinschmidt, Wolfgang Fischbach.   

Abstract

BACKGROUND: Irinotecan is an established therapeutic option in colorectal cancer. An essential side effect of irinotecan treatment is the induction of severe WHO grade 3-4 delayed diarrhea in up to 25% of treated patients. The aim of the study is the prevention of delayed diarrhea with cholestyramine/levofloxacin. PATIENTS AND METHODS: Fifty-one patients with a mean age of 64 years (range: 41-81 years) with metastatic colorectal cancer in second-line treatment were included. A cycle corresponds to 4 applications of irinotecan 250 mg/m2, every 2 weeks, then a break of 2 weeks.
RESULTS: After 1 treatment cycle 12% of patients achieved a partial response, 59% had stable disease and 29% progressive disease. Twenty-two patients received a second or more cycles to a total of 379 applications. Forty patients did not develop diarrhea whereas 11 patients had WHO 1-2 diarrhea after at least 1 application of chemotherapy. Diarrhea WHO 3 occurred in only 1 patient (2%) whereas severe diarrhea WHO 4 did not occur.
CONCLUSION: The combination of cholestyramine/levofloxacin is a promising option for the prevention of delayed diarrhea caused by irinotecan. This prophylactic regime may help in future to escalate the dose of irinotecan as a monotherapy or in combination protocols. Copyright 2007 S. Karger AG, Basel.

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Year:  2007        PMID: 17998785     DOI: 10.1159/000111083

Source DB:  PubMed          Journal:  Oncology        ISSN: 0030-2414            Impact factor:   2.935


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