Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008281
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2001-01-06
Brief Title:
Comparison of Three Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Sanofi
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicenter Open-Label Randomized Three-Arm Study Of 5-Fluorouracil 5-FU Plus Leucovorin LV Or Oxaliplatin Or A Combination Of 5-Fu LV Oxaliplatin As Second-Line Treatment Of Metastatic Colorectal Carcinoma
Status:
UNKNOWN
Status Verified Date:
2002-04
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 It is not yet known which regimen of chemotherapy is more effective for metastatic colorectal cancer
PURPOSE Phase III trial to compare the effectiveness of three chemotherapy regimens in treating patients who have metastatic colorectal cancer
PURPOSE Phase III trial to compare the effectiveness of three chemotherapy regimens in treating patients who have metastatic colorectal cancer
Detailed Description:
OBJECTIVES I Compare the overall survival of patients with metastatic colorectal carcinoma treated with fluorouracil and leucovorin calcium with vs without oxaliplatin vs oxaliplatin alone II Compare the response rate time to tumor-related symptomatic worsening time to disease progression onset and duration of complete and partial responses and duration of disease stabilization in patients treated with these regimens III Determine the safety profile 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 1 vs 2 or more and LDH value up to 15 times upper limit of normal ULN vs greater than 15 times ULN Patients are randomized to one of three treatment arms Arm I Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22 hours on days 1 and 2 Arm II Patients receive oxaliplatin IV over 2 hours on day 1 Arm III Patients receive oxaliplatin IV concurrently with leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22 hours on day 1 Leucovorin calcium and fluorouracil are administered alone on day 2 on the same schedule as on day 1 Treatment repeats every 2 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity Patients are followed for 30 days every 2 weeks for up to 3 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 786 patients 262 per arm will be accrued for this study within 12 months
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 1 vs 2 or more and LDH value up to 15 times upper limit of normal ULN vs greater than 15 times ULN Patients are randomized to one of three treatment arms Arm I Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22 hours on days 1 and 2 Arm II Patients receive oxaliplatin IV over 2 hours on day 1 Arm III Patients receive oxaliplatin IV concurrently with leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22 hours on day 1 Leucovorin calcium and fluorouracil are administered alone on day 2 on the same schedule as on day 1 Treatment repeats every 2 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity Patients are followed for 30 days every 2 weeks for up to 3 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 786 patients 262 per arm will be accrued for this study within 12 months
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 |
|---|---|---|---|
| BRCC-00036 | None | None | None |
| SANOFI-EFC4584 | None | None | None |