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NCT00003057 Clinical Trial

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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00003057
Other study ID # CDR0000065713
Secondary ID E-E1295CLB-9770S
Status Completed
Phase Phase 3
First received
Last updated
Start date March 26, 1997

Study information
Verified date June 2023
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date
Est. primary completion date May 2000
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• loperamide hydrochloride

• octreotide acetate

Locations
Country Name City State
United States Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Vermont Cancer Center Burlington Vermont
United States Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States University of Chicago Cancer Research Center Chicago Illinois
United States University of Illinois at Chicago Health Sciences Center Chicago Illinois
United States Ellis Fischel Cancer Center - Columbia Columbia Missouri
United States Duke Comprehensive Cancer Center Durham North Carolina
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States University of California San Diego Cancer Center La Jolla California
United States CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada
United States Norris Cotton Cancer Center Lebanon New Hampshire
United States CCOP - North Shore University Hospital Manhasset New York
United States North Shore University Hospital Manhasset New York
United States University of Tennessee, Memphis Cancer Center Memphis Tennessee
United States CCOP - Mount Sinai Medical Center Miami Beach Florida
United States University of Minnesota Cancer Center Minneapolis Minnesota
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Mount Sinai Medical Center, NY New York New York
United States New York Presbyterian Hospital - Cornell Campus New York New York
United States University of Nebraska Medical Center Omaha Nebraska
United States Rhode Island Hospital Providence Rhode Island
United States MBCCOP - Massey Cancer Center Richmond Virginia
United States Barnes-Jewish Hospital Saint Louis Missouri
United States UCSF Cancer Center and Cancer Research Institute San Francisco California
United States CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse New York
United States State University of New York - Upstate Medical University Syracuse New York
United States Walter Reed Army Medical Center Washington District of Columbia
United States CCOP - Christiana Care Health Services Wilmington Delaware
United States CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina
United States Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem North Carolina
United States University of Massachusetts Memorial Medical Center Worcester Massachusetts

Sponsors (4)
Lead Sponsor Collaborator
Eastern Cooperative Oncology Group Cancer and Leukemia Group B, National Cancer Institute (NCI), SWOG Cancer Research Network

Country where clinical trial is conducted

United States, 

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