Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016198
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2001-05-06
Brief Title:
Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer
Sponsor:
Prologue Research International
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Multicenter Phase II Study Of BolusInfusion 5-FULV de Gramont Regimen Versus Oxaliplatin And BolusInfusion 5-FULV de Gramont Regimen As Third-Line Treatment Of Patients With Metastatic Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2010-12
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 Combining more than one drug may kill more tumor cells
PURPOSE Randomized phase II trial to study the effectiveness of combining fluorouracil and leucovorin with or without oxaliplatin in treating patients who have recurrent metastatic colorectal cancer
PURPOSE Randomized phase II trial to study the effectiveness of combining fluorouracil and leucovorin with or without oxaliplatin in treating patients who have recurrent metastatic colorectal cancer
Detailed Description:
OBJECTIVES I Compare the overall response rate and overall survival of patients with recurrent metastatic colorectal adenocarcinoma treated with third-line therapy comprising fluorouracil and leucovorin calcium with or without oxaliplatin II Compare the onset and duration of complete and partial responses and duration of disease stabilization in patients treated with these regimens III Compare the proportion of patients with stable disease and proportion of patients with tumor-related symptomatic improvement treated with these regimens IV Compare the time to disease progression and time to tumor-related symptomatic worsening in patients treated with these 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 and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on days 1 and 2 Arm II Patients receive oxaliplatin IV over 2 hours leucovorin calcium IV over 2 hours and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on day 1 On day 2 patients receive leucovorin calcium and fluorouracil as in arm I Treatment in both arms repeats every 2 weeks for at least 1 year in the absence of disease progression Patients are followed at day 30 and then for approximately 6 months
PROJECTED ACCRUAL A total of 200 patients 100 per treatment arm will be accrued for this study
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 and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on days 1 and 2 Arm II Patients receive oxaliplatin IV over 2 hours leucovorin calcium IV over 2 hours and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on day 1 On day 2 patients receive leucovorin calcium and fluorouracil as in arm I Treatment in both arms repeats every 2 weeks for at least 1 year in the absence of disease progression Patients are followed at day 30 and then for approximately 6 months
PROJECTED ACCRUAL A total of 200 patients 100 per treatment 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 |
|---|---|---|---|
| SANOFI-EFC4760 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068606 | REGISTRY | None | None |