Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006115
Status:
UNKNOWN
Last Update Posted:
2009-01-13
First Post:
2000-08-03
Brief Title:
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Alternation of FOLFOX6 Oxaliplatin - Leucovorin - Fluorouracil and FOLFIRI Irinotecan - Leucovorin - Fluorouracil as Second Line Treatment of Metastatic Colorectal Cancer
Status:
UNKNOWN
Status Verified Date:
2002-01
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
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer that has not responded to previous chemotherapy
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer that has not responded to previous chemotherapy
Detailed Description:
OBJECTIVES I Determine the efficacy of oxaliplatin leucovorin calcium and fluorouracil followed by irinotecan leucovorin calcium and fluorouracil in terms of progression free survival in patients with metastatic colorectal cancer II Evaluate these treatment regimens in terms of overall survival response rate toxicity and quality of life in this patient population
OUTLINE This is a multicenter study Patients receive 4 courses of oxaliplatin IV and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours Following the initial 4 courses of therapy patients receive 4 courses of irinotecan IV over 30-90 minutes and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity Quality of life is assessed every 8 weeks Patients are followed every 3 months until death
PROJECTED ACCRUAL A total of 14-39 patients will be accrued for this study over 12 months
OUTLINE This is a multicenter study Patients receive 4 courses of oxaliplatin IV and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours Following the initial 4 courses of therapy patients receive 4 courses of irinotecan IV over 30-90 minutes and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity Quality of life is assessed every 8 weeks Patients are followed every 3 months until death
PROJECTED ACCRUAL A total of 14-39 patients will be accrued for this study over 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 |
|---|---|---|---|
| EU-20023 | None | None | None |
| FRE-GERCOR-C98-3-FIREFOX | None | None | None |