title: 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.
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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: I. Medizinische Klinik, GP-Klinikum Russelsheim, Russelsheim, Germany. d.flieger@uni-bonn.de
authors.forename: Dimitri
authors.initials: D
authors.lastname: Flieger
authors.forename: Christine
authors.initials: C
authors.lastname: Klassert
authors.forename: Sabine
authors.initials: S
authors.lastname: Hainke
authors.forename: Ralf
authors.initials: R
authors.lastname: Keller
authors.forename: Rolf
authors.initials: R
authors.lastname: Kleinschmidt
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Fischbach
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000930:Antidiarrheals / Q000627:therapeutic use*; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002792:Cholestyramine Resin / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D003967:Diarrhea / Q000139:chemically induced / Q000517:prevention & control*; D005260:Female; D006801:Humans; D000077146:Irinotecan; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000627:therapeutic use*; D013997:Time Factors
chemical_list: D000930:Antidiarrheals; D002792:Cholestyramine Resin; D064704:Levofloxacin; D000077146:Irinotecan; D015242:Ofloxacin; D002166:Camptothecin