Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004885
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2000-03-07
Brief Title:
Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
CPT-11 in Combination With Weekly 24 Hour Infusion 5-FU Plus Folinic Acid Relative to Weekly 24 Hour Infusion 5-FU Plus Folinic Acid Alone in Patients With Advanced Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2012-09
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 whether fluorouracil and leucovorin plus irinotecan is more effective than fluorouracil and leucovorin alone for colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of fluorouracil and leucovorin with or without irinotecan in treating patients who have metastatic colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of fluorouracil and leucovorin with or without irinotecan in treating patients who have metastatic colorectal cancer
Detailed Description:
OBJECTIVES I Compare the efficacy and toxicity of high-dose fluorouracil and leucovorin calcium with or without irinotecan in patients with metastatic adenocarcinoma of the colon or rectum II Compare progression-free survival overall survival response rate and duration of response in patients treated with these 2 regimens III Compare quality of life of patients treated with these 2 regimens
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on days 1 8 15 22 29 and 36 Arm II Patients receive irinotecan IV over 30 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV over 24 hours on days 1 8 15 22 29 and 36 Treatment in both arms repeats every 7 weeks in the absence of disease progression or unacceptable toxicity Patients in arm I who develop disease progression begin second-line therapy comprising irinotecan fluorouracil and leucovorin calcium within 2 months of progression Patients with complete response are taken off study after receiving treatment for one year Quality of life is assessed before beginning study after completion of each course at 4 weeks after completion of study and then every 2 months until disease progression or death Patients are followed every 2 months until disease progression or death
PROJECTED ACCRUAL A total of 430 patients 215 per arm will be accrued for this study within 2 years
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on days 1 8 15 22 29 and 36 Arm II Patients receive irinotecan IV over 30 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV over 24 hours on days 1 8 15 22 29 and 36 Treatment in both arms repeats every 7 weeks in the absence of disease progression or unacceptable toxicity Patients in arm I who develop disease progression begin second-line therapy comprising irinotecan fluorouracil and leucovorin calcium within 2 months of progression Patients with complete response are taken off study after receiving treatment for one year Quality of life is assessed before beginning study after completion of each course at 4 weeks after completion of study and then every 2 months until disease progression or death Patients are followed every 2 months until disease progression or death
PROJECTED ACCRUAL A total of 430 patients 215 per arm will be accrued for this study within 2 years
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 |
|---|---|---|---|
| EORTC-40986 | None | None | None |