Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012389
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2001-03-03
Brief Title:
Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Sanofi
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicenter Open-Label Randomized Two-Arm Study of Irinotecan CPT-11 Versus the Combination of Oxaliplatin Irinotecan CPT-11 as Second-Line Treatment of Metastatic Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2002-10
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 used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known if irinotecan is more effective with or without oxaliplatin in treating metastatic colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of irinotecan with or without oxaliplatin in treating patients who have metastatic colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of irinotecan with or without oxaliplatin in treating patients who have metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Compare the overall survival of patients with metastatic colorectal cancer treated with irinotecan with or without oxaliplatin
Compare the response rate time to tumor-related worsening of symptoms time to disease progression onset and duration of responses and duration of disease stabilization in these patients treated with these regimens
Compare the safety of these regimens in these patients
OUTLINE This is a randomized open label multicenter study Patients are stratified according to Karnofsky performance status 50-60 vs 70-100 number of metastatic organs involved 1 vs 2 or more lactic dehydrogenase no greater than 15 times upper limit of normal ULN vs greater than 15 times ULN and prior fluorouracil chemotherapy adjuvant vs first-line treatment for metastatic disease Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive irinotecan IV over 90 minutes on day 1
Arm II Patients receive oxaliplatin IV over 120 minutes followed by irinotecan IV over 30 minutes on day 1
Courses repeat in each arm every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed at 30 days every 4 weeks for 3 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 596 patients 298 per arm will be accrued for this study within 18 months
Compare the overall survival of patients with metastatic colorectal cancer treated with irinotecan with or without oxaliplatin
Compare the response rate time to tumor-related worsening of symptoms time to disease progression onset and duration of responses and duration of disease stabilization in these patients treated with these regimens
Compare the safety of these regimens in these patients
OUTLINE This is a randomized open label multicenter study Patients are stratified according to Karnofsky performance status 50-60 vs 70-100 number of metastatic organs involved 1 vs 2 or more lactic dehydrogenase no greater than 15 times upper limit of normal ULN vs greater than 15 times ULN and prior fluorouracil chemotherapy adjuvant vs first-line treatment for metastatic disease Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive irinotecan IV over 90 minutes on day 1
Arm II Patients receive oxaliplatin IV over 120 minutes followed by irinotecan IV over 30 minutes on day 1
Courses repeat in each arm every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed at 30 days every 4 weeks for 3 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 596 patients 298 per arm will be accrued for this study within 18 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SANOFI-EFC4585 | None | None | None |