Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT00075595
Status:
UNKNOWN
Last Update Posted:
2009-01-06
First Post:
2004-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
Study Overview
Official Title:
Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer
Status:
UNKNOWN
Status Verified Date:
2007-08
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, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic unresectable colorectal cancer.
PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic unresectable colorectal cancer.
Detailed Description:
OBJECTIVES:
Primary
* Determine the time to progression and time to death from progression in patients with recurrent or refractory metastatic unresectable colorectal cancer treated with fluorouracil, leucovorin calcium, and irinotecan.
Secondary
* Determine the objective response and stabilization rate in patients treated with this regimen.
* Determine the time to treatment failure in patients treated with this regimen.
* Determine the duration of response in patients treated with this regimen.
* Determine overall survival rate in patients treated with this regimen.
* Determine the incidence of grade 3 or 4 toxicity in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive leucovorin calcium IV over 2 hours on day 1, irinotecan IV over 1 hour on days 1 and 3, and fluorouracil IV continuously over 46 hours beginning on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 18 months.
Primary
* Determine the time to progression and time to death from progression in patients with recurrent or refractory metastatic unresectable colorectal cancer treated with fluorouracil, leucovorin calcium, and irinotecan.
Secondary
* Determine the objective response and stabilization rate in patients treated with this regimen.
* Determine the time to treatment failure in patients treated with this regimen.
* Determine the duration of response in patients treated with this regimen.
* Determine overall survival rate in patients treated with this regimen.
* Determine the incidence of grade 3 or 4 toxicity in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive leucovorin calcium IV over 2 hours on day 1, irinotecan IV over 1 hour on days 1 and 3, and fluorouracil IV continuously over 46 hours beginning on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 78 patients 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?: