Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077233
Status:
TERMINATED
Last Update Posted:
2018-05-16
First Post:
2004-02-10
Brief Title:
FOLFIRI or FOLFOX With or Without Cetuximab in Patients With Metastatic Adenocarcinoma of the Colon or Rectum
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Trial Of Irinotecan 5-FU Leucovorin Or Oxaliplatin 5-FU Leucovorin With And Without Cetuximab C225 For Patients With Untreated Metastatic Adenocarcinoma Of The Colon or Rectum
Status:
TERMINATED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized phase II study trial that has served as a screening trial to test the increased efficacy of chemotherapy cetuximab versus chemotherapy alone among patients with untreated advanced or metastatic colon cancer regardless of tumor status with respect to EGFR
Detailed Description:
CALGB 80203 was activated on December 15 2003 In February 2004 based on the results of the randomized trial of IFL - cetuximab showing a significant improvement in overall survival with cetuximab cetuximab was approved by the FDA for use as front-line therapy for patients with metastatic colon cancer In response to this action the Data Safety and Monitoring Board recommended closure of CALGB 80203 CALGB 80203 was subsequently closed to accrual in January 2005 with 238 of the originally targeted 2200 patients enrolled A final decision was to replace CALGB 80203 with a three-treatment arm randomized trial of chemotherapy FOLFOX or FOLFIRI with and without cetuximab andor bevacizumab The protocol was amended to allow analysis of the data from CALGB 80203 as a randomized phase II trial and reporting of the results
Patients were stratified according to prior adjuvant chemotherapy yes vs no and prior pelvic radiation yes vs no Patients must have completed any major surgery or radiotherapy eg chest or bone palliative RT or pelvic RT 4 weeks from registration and completed any minor surgery 2 weeks from registration Patients must have fully recovered from the procedure andor radiotherapy Patients must have initiated treatment within 7 days of registration Patients were randomized to 1 of 4 treatment arms please see a description of the treatment regimens in the Arms section In addition patients received concomitant and supportive therapy as appropriate per the protocol
OBJECTIVES
Primary
1 To determine if the addition of C225 to FOLFIRI or FOLFOX chemotherapy prolongs survival of patients with untreated advanced or metastatic colorectal cancer
Secondary
1 To determine if the FOLFIRI and FOLFOX regimens are equivalent in terms of survival as front-line therapy for advanced colorectal patients
2 To determine the level of EGFR expression in patients with metastatic colorectal cancer
Patients were followed up to 3 years post-treatment
Patients were stratified according to prior adjuvant chemotherapy yes vs no and prior pelvic radiation yes vs no Patients must have completed any major surgery or radiotherapy eg chest or bone palliative RT or pelvic RT 4 weeks from registration and completed any minor surgery 2 weeks from registration Patients must have fully recovered from the procedure andor radiotherapy Patients must have initiated treatment within 7 days of registration Patients were randomized to 1 of 4 treatment arms please see a description of the treatment regimens in the Arms section In addition patients received concomitant and supportive therapy as appropriate per the protocol
OBJECTIVES
Primary
1 To determine if the addition of C225 to FOLFIRI or FOLFOX chemotherapy prolongs survival of patients with untreated advanced or metastatic colorectal cancer
Secondary
1 To determine if the FOLFIRI and FOLFOX regimens are equivalent in terms of survival as front-line therapy for advanced colorectal patients
2 To determine the level of EGFR expression in patients with metastatic colorectal cancer
Patients were followed up to 3 years post-treatment
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 |
|---|---|---|---|
| CDR0000350016 | OTHER | Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |