Trials / Completed
CompletedNCT00003057
Octreotide Compared With Loperamide Hydrochloride for Chemotherapy-Related Diarrhea in Patients With Colorectal Cancer
Randomized Trial of High-Dose Versus Conventional Dose Octreotide Acetate Versus Loperamide in the Treatment of Chemotherpay-Related Diarrhea in Patients With Colorectal Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Eastern Cooperative Oncology Group · Network
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | loperamide hydrochloride | |
| DRUG | octreotide acetate |
Timeline
- Start date
- 1997-03-26
- Primary completion
- 2000-05-01
- First posted
- 2004-07-19
- Last updated
- 2023-06-18
Locations
33 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00003057. Inclusion in this directory is not an endorsement.