Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072553
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
2003-11-04
Brief Title:
Celecoxib Leucovorin Fluorouracil and Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Of An Optimized LV-5FU-Oxaliplatin Strategy With Celebrex In Metastatic Colorectal Cancer Optimox2-Celecoxib Study
Status:
UNKNOWN
Status Verified Date:
2007-05
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 leucovorin fluorouracil and oxaliplatin use different ways to stop tumor cells from dividing so they stop growing or die Celecoxib may stop the growth of colorectal cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth Combining chemotherapy with celecoxib may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining celecoxib with leucovorin fluorouracil and oxaliplatin in treating patients who have metastatic colorectal cancer
PURPOSE Phase II trial to study the effectiveness of combining celecoxib with leucovorin fluorouracil and oxaliplatin in treating patients who have metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with metastatic colorectal cancer treated with celecoxib leucovorin calcium fluorouracil and oxaliplatin
Secondary
Determine the toxicity of this regimen in these patients
Determine the time of disease control to evaluate progression-free survival in patients treated with this regimen
Determine the salvage surgery rate in patients treated with this regimen
Determine the duration of chemotherapy-free intervals in patients treated with this regimen
Determine the tolerability of this regimen in these patients
Determine the quality of life of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive FOLFOX7 chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1 Patients also receive oral celecoxib twice daily beginning on day 1 Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease stop treatment If disease progression occurs during the chemotherapy-free interval patients receive an additional 6 courses
Patients with responding disease after receiving at least 6 courses of chemotherapy may undergo surgery Beginning within 10 weeks after surgery patients receive simplified LV5FU2 chemotherapy comprising leucovorin calcium IV over 2 hours on day 1 fluorouracil IV over 46 hours beginning on day 1 and oral celecoxib twice daily beginning on day 1 Treatment repeats every 14 days for at least 12 courses
Quality of life is assessed at baseline during courses 4 and 6 and then every 2 months thereafter
Patients are followed at 1 month and then every 2 months thereafter
PROJECTED ACCRUAL A total of 39 patients will be accrued for this study
Primary
Determine the response rate in patients with metastatic colorectal cancer treated with celecoxib leucovorin calcium fluorouracil and oxaliplatin
Secondary
Determine the toxicity of this regimen in these patients
Determine the time of disease control to evaluate progression-free survival in patients treated with this regimen
Determine the salvage surgery rate in patients treated with this regimen
Determine the duration of chemotherapy-free intervals in patients treated with this regimen
Determine the tolerability of this regimen in these patients
Determine the quality of life of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive FOLFOX7 chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1 Patients also receive oral celecoxib twice daily beginning on day 1 Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease stop treatment If disease progression occurs during the chemotherapy-free interval patients receive an additional 6 courses
Patients with responding disease after receiving at least 6 courses of chemotherapy may undergo surgery Beginning within 10 weeks after surgery patients receive simplified LV5FU2 chemotherapy comprising leucovorin calcium IV over 2 hours on day 1 fluorouracil IV over 46 hours beginning on day 1 and oral celecoxib twice daily beginning on day 1 Treatment repeats every 14 days for at least 12 courses
Quality of life is assessed at baseline during courses 4 and 6 and then every 2 months thereafter
Patients are followed at 1 month and then every 2 months thereafter
PROJECTED ACCRUAL A total of 39 patients will be accrued for this study
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20325 | None | None | None |
| GERCOR-OPTIMOX2-CELECOXIB-2002 | None | None | None |