Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006468
Status:
UNKNOWN
Last Update Posted:
2009-01-13
First Post:
2000-11-06
Brief Title:
Comparing Two Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of An Optimized LV-5FU-Oxaliplatin Regimen in Metastatic Colorectal Cancer C99-1
Status:
UNKNOWN
Status Verified Date:
2000-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Combining more than one drug may kill more tumor cells It is not yet known which regimen of combination chemotherapy is more effective for metastatic colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have metastatic colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of intermittent high-dose oxaliplatin in combination with a simplified bimonthly regimen of leucovorin calcium LV and fluorouracil 5-FU vs standard dose oxaliplatin in combination with the standard bimonthly regimen of LV and 5-FU in patients with metastatic colorectal cancer
Determine the time to treatment failure tolerance response rate and overall survival in patients treated with these 2 regimens
Compare quality of life of these patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to treatment center performance status 0-1 vs 2 and number of metastatic sites 1 vs more than 1 Patients are randomized to one of two treatment arms
Arm I Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours followed by fluorouracil 5-FU IV over 22 hours on days 1 and 2
Arm II Patients receive oxaliplatin IV and leucovorin calcium IV over 2 hours followed by 5-FU IV over 46 hours beginning on day 1 for courses 1-6 and 19-24 For courses 7-18 patients receive leucovorin calcium IV followed by 5-FU IV as above beginning on day 1
Courses repeat every 14 days in both arms in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline after courses 4 and 6 and every 6 courses thereafter
Patients are followed monthly for 3 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 460 patients 230 per treatment arm will be accrued for this study within 18 months
Compare the efficacy of intermittent high-dose oxaliplatin in combination with a simplified bimonthly regimen of leucovorin calcium LV and fluorouracil 5-FU vs standard dose oxaliplatin in combination with the standard bimonthly regimen of LV and 5-FU in patients with metastatic colorectal cancer
Determine the time to treatment failure tolerance response rate and overall survival in patients treated with these 2 regimens
Compare quality of life of these patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to treatment center performance status 0-1 vs 2 and number of metastatic sites 1 vs more than 1 Patients are randomized to one of two treatment arms
Arm I Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours followed by fluorouracil 5-FU IV over 22 hours on days 1 and 2
Arm II Patients receive oxaliplatin IV and leucovorin calcium IV over 2 hours followed by 5-FU IV over 46 hours beginning on day 1 for courses 1-6 and 19-24 For courses 7-18 patients receive leucovorin calcium IV followed by 5-FU IV as above beginning on day 1
Courses repeat every 14 days in both arms in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline after courses 4 and 6 and every 6 courses thereafter
Patients are followed monthly for 3 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 460 patients 230 per treatment 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 |
|---|---|---|---|
| EU-20034 | None | None | None |
| FRE-GERCOR-OPTIMOX-2000 | None | None | None |