Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039611
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2002-06-06
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Oxaliplatin NSC 266046 in Combination With 5-Fluorouracil and Leucovorin FOLFOX4 for Patients Who Have Not Received Prior Chemotherapy for Advanced Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2002-07
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 cancer cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Clinical trial to study the effectiveness of combination chemotherapy in treating patients who have advanced colorectal cancer
PURPOSE Clinical trial to study the effectiveness of combination chemotherapy in treating patients who have advanced colorectal cancer
Detailed Description:
OBJECTIVES
Provide oxaliplatin in combination with fluorouracil and leucovorin calcium using the FOLFOX4 regimen for front-line treatment in patients with no prior chemotherapy for advanced colorectal cancer who are not eligible for entry into ongoing clinical trials of higher priority The regimen in this Treatment Referral Center protocol is one that was found to be superior in a recent national intergroup study
Further determine the safety of this regimen in these patients
Further determine the anti-tumor activity of this regimen defined as the rate of time-to-treatment failure time to progression and survival in these patients
Capture data on subsequent salvage therapy administered to patients treated with this protocol
OUTLINE This is an open-label multicenter study
Patients receive oxaliplatin IV over 2 hours on day 1 leucovorin calcium IV over 2 hours on days 1 and 2 and fluorouracil IV over 22 hours on days 1 and 2 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity Patients with clinical evidence of benefit from this treatment defined as stable disease partial response or complete response as well as no increase in size of any measurable or evaluable lesion and no new sites of disease may be eligible for additional courses
Patients are followed until death
PROJECTED ACCRUAL A maximum of 300 patients per month will be accrued for this study
Provide oxaliplatin in combination with fluorouracil and leucovorin calcium using the FOLFOX4 regimen for front-line treatment in patients with no prior chemotherapy for advanced colorectal cancer who are not eligible for entry into ongoing clinical trials of higher priority The regimen in this Treatment Referral Center protocol is one that was found to be superior in a recent national intergroup study
Further determine the safety of this regimen in these patients
Further determine the anti-tumor activity of this regimen defined as the rate of time-to-treatment failure time to progression and survival in these patients
Capture data on subsequent salvage therapy administered to patients treated with this protocol
OUTLINE This is an open-label multicenter study
Patients receive oxaliplatin IV over 2 hours on day 1 leucovorin calcium IV over 2 hours on days 1 and 2 and fluorouracil IV over 22 hours on days 1 and 2 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity Patients with clinical evidence of benefit from this treatment defined as stable disease partial response or complete response as well as no increase in size of any measurable or evaluable lesion and no new sites of disease may be eligible for additional courses
Patients are followed until death
PROJECTED ACCRUAL A maximum of 300 patients per month 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 |
|---|---|---|---|
| CTEP-TRC-0201 | None | None | None |