Randomized Trial of High-Dose Versus Conventional Dose Octreotide Acetate Versus Loperamide in the Treatment of Chemotherpay-Related Diarrhea in Patients With Colorectal Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed colorectal carcinoma At least grade 2
diarrhea as a consequence of chemotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Other: Concurrent enrollment into SWOG-9420 protocol allowed No sensitivity to octreotide
acetate or loperamide hydrochloride Eligible if less than 24 hours since prior loperamide
or octreotide and no resolution of diarrhea Not pregnant or lactating Effective
contraception required of fertile patients Not HIV positive No idiopathic ulcerative
colitis or Crohn's disease, acute stool culture positive bacterial colitis,
pseudomembranous colitis, short bowel syndrome, enteroenteric fistulae, chronic
pancreatitis, ischemic bowel disease, or gastrointestinal disorders known to cause
diarrhea Absence of definitive culture results required

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy
with a fluoropyrimidine alone or in combination with an accepted modulating agent
(leucovorin, levamisole, methotrexate, interferon, PALA, or hydroxyurea) required Prior
chemotherapy with uracil mustard and tegafur (UFT) allowed No concurrent chemotherapy
allowed during study Endocrine therapy: Not specified Radiotherapy: No whole pelvic or
abdominal radiation therapy allowed Surgery: No colectomy, coloanal anastamosis,
abdominoperineal resection, or colostomy allowed Other: No antidiarrheal agents (e.g.,
diphenoxylate hydrochloride, elixir paregoric, opium tincture or tincture of belladonna,
or kaolin) during study No cyclosporine allowed