Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006269
Status:
TERMINATED
Last Update Posted:
2012-05-25
First Post:
2000-09-11
Brief Title:
Octreotide in the Prevention of Diarrhea in Patients Receiving Irinotecan for Metastatic Colon Cancer
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Prospective Randomized Trial of Sandostatin LAR Depot for the Prevention of Irinotecan-Induced Diarrhea in Patients With Metastatic Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2012-05
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 Octreotide may be effective in preventing diarrhea that is caused by treatment with irinotecan
PURPOSE Randomized phase III trial to study the effectiveness of octreotide in preventing diarrhea in patients who are receiving irinotecan for metastatic colon cancer
PURPOSE Randomized phase III trial to study the effectiveness of octreotide in preventing diarrhea in patients who are receiving irinotecan for metastatic colon cancer
Detailed Description:
OBJECTIVES I Compare the incidence of grade 2-4 diarrhea after completion of irinotecan in patients with metastatic colorectal cancer treated with octreotide vs placebo II Compare the duration of diarrhea and need for irinotecan dose reduction delay and hospitalization in patients treated with these 2 regimens III Collect data on tumor response and 1 year survival in patients treated with these 2 regimens IV Determine the pharmacokinetics and interaction of irinotecan and octreotide in a subset of these patients
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified according to prior pelvic irradiation yes vs no age under 70 vs 70 and over and ECOG performance status 0 vs 1 or 2 Patients are randomized to 1 of 2 treatment arms Arm I Patients receive octreotide intramuscularly IM once Beginning 10-14 days later patients receive irinotecan IV over 90 minutes on day 1 Patients also receive octreotide IM on the same day as irinotecan Arm II Patients receive placebo IM once Beginning 10-14 days later patients receive irinotecan as in arm I Patients also receive placebo IM on the same day as irinotecan Therapy continues every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months through year 1
PROJECTED ACCRUAL A total of 300 patients 150 per arm will be accrued for this study
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified according to prior pelvic irradiation yes vs no age under 70 vs 70 and over and ECOG performance status 0 vs 1 or 2 Patients are randomized to 1 of 2 treatment arms Arm I Patients receive octreotide intramuscularly IM once Beginning 10-14 days later patients receive irinotecan IV over 90 minutes on day 1 Patients also receive octreotide IM on the same day as irinotecan Arm II Patients receive placebo IM once Beginning 10-14 days later patients receive irinotecan as in arm I Patients also receive placebo IM on the same day as irinotecan Therapy continues every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months through year 1
PROJECTED ACCRUAL A total of 300 patients 150 per arm will be accrued for this study
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 |
|---|---|---|---|
| NOVARTIS-CSMS995US05 | None | None | None |