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.
Interventional
Allocation: Randomized, Primary Purpose: Supportive Care
Scott Wadler, MD
Study Chair
Albert Einstein College of Medicine of Yeshiva University
United States: Federal Government
CDR0000065713
NCT00003057
November 1996
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
University of Tennessee, Memphis Cancer Center | Memphis, Tennessee 38103 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
North Shore University Hospital | Manhasset, New York 11030 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
University of Illinois at Chicago Health Sciences Center | Chicago, Illinois 60612 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |