Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003057
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
1999-11-01
Brief Title:
Octreotide Compared With Loperamide Hydrochloride for Chemotherapy-Related Diarrhea in Patients With Colorectal Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P97-0081 | None | None | None |
| E-E1295 | None | None | None |
| CLB-9770 | None | None | None |
| SWOG-E1295 | None | None | None |