A phase II study of CPT 11 (irinotecan) in refractory to 5 FU colorectal cancer with curative treatment of delayed diarrhea by acetorphan

Due to its secretory type, CPT 11-induced diarrhea might be controlled by loperamide (L) and Acetorphan (A) combination, two-drugs with complementary antisecretory mechanisms of action: inhibition of Ca++/Calmodulins complex and inhibition of enkephalinase, respectively. Preliminary results as an ongoing pilot study aimed to determine the precise etiology of diarrhea, support this hypothesis. In order to optimize the curative intent anti-diarrheal treatment, we performed an open label phase II randomized study comparing high dose Acetorphan versus combined Acerorphan + Loperamide: (A) 200 mg × 3 per day versus (A) 100 mg × 3 + (L) 4 mg × 3 per day. Sixty-two patients with advanced colorectal cancer refractory to 5 FU received CPT 11 at the dose of 350 mg/m2 every 3 weeks. Only 27 are so far evaluable. However is too early to draw any conclusion. Final result will be presented.