Colon Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility 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

Study is for people with:

Colon Cancer

Phase:

Phase 3

Estimated Enrollment:

500

Study ID:

NCT00003057

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 30 Locations for this study

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University of California San Diego Cancer Center
La Jolla California, 92093, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco California, 94115, United States
CCOP - Christiana Care Health Services
Wilmington Delaware, 19899, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
University of Illinois at Chicago Health Sciences Center
Chicago Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore Maryland, 21201, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
University of Massachusetts Memorial Medical Center
Worcester Massachusetts, 01655, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
Ellis Fischel Cancer Center - Columbia
Columbia Missouri, 65203, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Norris Cotton Cancer Center
Lebanon New Hampshire, 03756, United States
CCOP - North Shore University Hospital
Manhasset New York, 11030, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
New York Presbyterian Hospital - Cornell Campus
New York New York, 10021, United States
Mount Sinai Medical Center, NY
New York New York, 10029, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse New York, 13210, United States
State University of New York - Upstate Medical University
Syracuse New York, 13210, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina, 27599, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem North Carolina, 27104, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
University of Tennessee, Memphis Cancer Center
Memphis Tennessee, 38163, United States
Vermont Cancer Center
Burlington Vermont, 05401, United States
MBCCOP - Massey Cancer Center
Richmond Virginia, 23298, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 3

Estimated Enrollment:

500

Study ID:

NCT00003057

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

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