Octreotide Compared With Loperamide Hydrochloride for Chemotherapy-Related Diarrhea in Patients With Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00003057|
Recruitment Status : Completed
First Posted : July 19, 2004
Last Update Posted : May 12, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Diarrhea||Drug: loperamide hydrochloride Drug: octreotide acetate||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Primary Purpose:||Supportive Care|
|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 Start Date :||November 1996|
|Actual Primary Completion Date :||May 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003057
|Study Chair:||Scott Wadler, MD||Albert Einstein College of Medicine|
|Study Chair:||Mace L. Rothenberg, MD, FACP||Vanderbilt-Ingram Cancer Center|
|Study Chair:||Bhoomi Mehrotra, MD||Long Island Jewish Medical Center|