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

Condition(s) targeted: Colorectal Cancer; Diarrhea

Intervention: loperamide hydrochloride (Drug); octreotide acetate (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Eastern Cooperative Oncology Group

Official(s) and/or principal investigator(s):
Scott Wadler, MD, Study Chair, Affiliation: Albert Einstein College of Medicine of Yeshiva University
Mace L. Rothenberg, MD, FACP, Study Chair, Affiliation: Vanderbilt-Ingram Cancer Center
Bhoomi Mehrotra, MD, Study Chair, Affiliation: Long Island Jewish Medical Center

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.

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

Study design: Supportive Care, Randomized

Detailed 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

UCSF Cancer Center and Cancer Research Institute, San Francisco, California 94115-0128, United States

University of California San Diego Cancer Center, La Jolla, California 92093-0658, United States

CCOP - Christiana Care Health Services, Wilmington, Delaware 19899, United States

Walter Reed Army Medical Center, Washington, District of Columbia 20307-5000, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida 33140, United States

University of Chicago Cancer Research Center, Chicago, Illinois 60637, United States

University of Illinois at Chicago Health Sciences Center, Chicago, Illinois 60612, 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

Barnes-Jewish Hospital, Saint Louis, Missouri 63110, United States

Ellis Fischel Cancer Center - Columbia, Columbia, Missouri 65203, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198-3330, 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

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York 13210, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States

Mount Sinai Medical Center, NY, New York, New York 10029, United States

New York Presbyterian Hospital - Cornell Campus, New York, New York 10021, United States

North Shore University Hospital, Manhasset, New York 11030, United States

State University of New York - Upstate Medical University, Syracuse, New York 13210, United States

CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina 27104-4241, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157-1082, United States

Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina 27599-7295, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Medical University of South Carolina, Charleston, South Carolina 29425-0721, United States

University of Tennessee, Memphis Cancer Center, Memphis, Tennessee 38163, United States

Vermont Cancer Center, Burlington, Vermont 05401-3498, United States

MBCCOP - Massey Cancer Center, Richmond, Virginia 23298-0037, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: November 1996
Last updated: May 23, 2008