Background: A prospective trial was conducted involving 16 patients with colorectal adenocarcinoma using a regimen of continuous-infusion octreotide acetate (Sandostatin [octreotide acetate], Sandoz, East Hanover, NJ for the treatment of severe diarrhea induced by the weekly schedule of 5-fluorouracil (5-FU) in combination with leucovorin who were refractory to opiate therapy.

Methods: Fifteen patients had tissue-documented metastatic colorectal adenocarcinoma. An additional patient was treated adjuvantly. Fifteen patients were treated with chemotherapy consisting of 5-FU and high-dose leucovorin. The octreotide acetate regimen used was a continuous infusion of 50 micrograms/h for 12 hours followed by 100 micrograms/h for 12 hours and subsequently 150 micrograms/h for 72 hours. All patients were previous failures of diphenoxylate atropine (Lomotil diphenoxalate], Searle, Chicago, IL) given 2.5 mg orally after each loose bowel movement, but no more than 20 mg in a 24-hour period. Opiate therapy was not continued beyond 48 hours. All patients also were treated with bowel rest (nothing by mouth) and intravenous fluid hydration as well as octreotide acetate.

Results: Complete resolution of diarrhea was seen in 15 of 16 patients (94%). In 4 patients this was accomplished during the 100 micrograms/h infusion, and in 11 patients during the 150 micrograms/h infusion. Recurrence of diarrhea was seen in two patients after a complete cycle of octreotide acetate. Both patients were restarted at 150 micrograms/h for 72 hours of octreotide acetate with resolution of the diarrhea within 36 hours of the infusion. No toxicity related to octreotide acetate was seen in this trial.

Conclusion: The continuous-infusion regimen of octreotide acetate 150 micrograms/h is an effective and safe schedule for the treatment of chemotherapy-induced diarrhea together with bowel rest and intravenous fluid hydration in a group of patients in whom the majority were treated with the weekly schedule of 5-FU and high-dose leucovorin.