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

Oncology. 2007;72(1-2):10-6. doi: 10.1159/000111083. Epub 2007 Nov 12.

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.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antidiarrheals / therapeutic use*
  • Camptothecin / adverse effects
  • Camptothecin / analogs & derivatives*
  • Camptothecin / therapeutic use
  • Cholestyramine Resin / therapeutic use*
  • Colorectal Neoplasms / drug therapy*
  • Diarrhea / chemically induced
  • Diarrhea / prevention & control*
  • Female
  • Humans
  • Irinotecan
  • Levofloxacin*
  • Male
  • Middle Aged
  • Ofloxacin / therapeutic use*
  • Time Factors

Substances

  • Antidiarrheals
  • Cholestyramine Resin
  • Levofloxacin
  • Irinotecan
  • Ofloxacin
  • Camptothecin