Octreotide Compared With Loperamide Hydrochloride for Chemotherapy-Related Diarrhea in Patients With Colorectal Cancer
Octreotide Compared With Loperamide Hydrochloride for Chemotherapy-Related Diarrhea in Patients With Colorectal Cancer
RATIONALE: Drugs such as octreotide and loperamide hydrochloride use different ways to
 relieve the diarrhea caused by chemotherapy.

 PURPOSE: Randomized phase III trial to compare the effectiveness of octreotide with
 loperamide hydrochloride for the treatment of chemotherapy-related diarrhea in patients who
 have colorectal cancer.
OBJECTIVES: I. Determine the safety and efficacy of octreotide acetate versus conventional
 therapy with loperamide hydrochloride for chemotherapy related diarrhea in patients with
 advanced colorectal malignancies undergoing chemotherapy with fluorouracil or fluorouracil
 based regimens.

 OUTLINE: This is a prospective, randomized, parallel, open label, multicenter study. Patients
 are stratified by therapy, grade of diarrhea, and prior use of loperamide hydrochloride or
 octreotide acetate. Patients undergo 1 of 3 treatments. Patients receive either low doses of
 octreotide (arm A) or high doses of octreotide (arm B) subcutaneously 3 times daily for 5
 days. Patients in arm C receive oral doses of loperamide following each unformed stool for 5
 days. A diary is completed by patients to record medications and bowel history. Treatment
 continues if diarrhea persists beyond day 5, but will be considered a treatment failure. If
 diarrhea continues to worsen, patients are removed from study. All patients are followed for
 24 days.

 PROJECTED ACCRUAL: This study will accrue a total of 500 patients.
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