Overview

Octreotide Compared With Loperamide Hydrochloride for Chemotherapy-Related Diarrhea in Patients With Colorectal Cancer

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborators:
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Southwest Oncology Group
Treatments:
Antidiarrheals
Loperamide
Octreotide
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