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

Last updated: June 14, 2023
Sponsor: Eastern Cooperative Oncology Group
Overall Status: Completed

Phase

3

Condition

Colorectal Cancer

Bowel Dysfunction

Colic

Treatment

octreotide acetate

loperamide hydrochloride

Clinical Study ID

NCT00003057
CDR0000065713
SWOG-E1295
CLB-9770
E-E1295
NCI-P97-0081
  • Ages 18-120
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: octreotide acetate
Phase: 3
Study Start date:
March 26, 1997
Estimated Completion Date:

Study Description

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.

Connect with a study center

  • University of California San Diego Cancer Center

    La Jolla, California 92093-0658
    United States

    Site Not Available

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California 94115-0128
    United States

    Site Not Available

  • CCOP - Christiana Care Health Services

    Wilmington, Delaware 19899
    United States

    Site Not Available

  • Walter Reed Army Medical Center

    Washington, District of Columbia 20307-5000
    United States

    Site Not Available

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • University of Chicago Cancer Research Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Illinois at Chicago Health Sciences Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri 65203
    United States

    Site Not Available

  • Barnes-Jewish Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198-3330
    United States

    Site Not Available

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • CCOP - North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10021
    United States

    Site Not Available

  • Mount Sinai Medical Center, NY

    New York, New York 10029
    United States

    Site Not Available

  • New York Presbyterian Hospital - Cornell Campus

    New York, New York 10021
    United States

    Site Not Available

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    Syracuse, New York 13210
    United States

    Site Not Available

  • State University of New York - Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina 27599-7295
    United States

    Site Not Available

  • Duke Comprehensive Cancer Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina 27104-4241
    United States

    Site Not Available

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina 27157-1082
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425-0721
    United States

    Site Not Available

  • University of Tennessee, Memphis Cancer Center

    Memphis, Tennessee 38163
    United States

    Site Not Available

  • Vermont Cancer Center

    Burlington, Vermont 05401-3498
    United States

    Site Not Available

  • MBCCOP - Massey Cancer Center

    Richmond, Virginia 23298-0037
    United States

    Site Not Available

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