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

Phase 3
18 Years
Not Enrolling
Colorectal Cancer, Diarrhea

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

Scott Wadler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University


United States: Federal Government

Study ID:




Start Date:

November 1996

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Diarrhea
  • colon cancer
  • rectal cancer
  • diarrhea
  • Colorectal Neoplasms
  • Diarrhea



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