Expired Study
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Fountain Valley, California 92708


Purpose:

The purpose of this study is to compare overall survival in patients with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone.


Criteria:

Inclusion Criteria: - Documented colorectal cancer which is EGFR-positive and is metastatic. - Prior irinotecan, alone or in combination, as first-line treatment of metastatic disease. Exclusion Criteria: - A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive protocol therapy. - Known dihydropyrimidine dehydrogenase (DPD) deficiency. - Known metastases in the central nervous system. - Symptomatic sensory or peripheral neuropathy. - More than one prior chemotherapy regimen for the treatment of metastatic colorectal cancer. - Prior oxaliplatin therapy. - Prior cetuximab or other therapy which targets the EGF pathway. - Prior chimerized or murine monoclonal antibody therapy.


Study is Available At:


Original ID:

CA225-014


NCT ID:

NCT00061815


Secondary ID:


Study Acronym:


Brief Title:

Study of Cetuximab, Oxaliplatin, 5-FU/LV Versus Oxaliplatin, 5-FU/LV in Patients With Previously Treated Metastatic, EGFR-Positive Colorectal Cancer


Official Title:

A Phase 3 Randomized Multicenter Study of Cetuximab, Oxaliplatin, 5-Fluorouracil, and Leucovorin vs. Oxaliplatin, 5-Fluorouracil, and Leucovorin in Subjects With Previously Treated Metastatic, EGFR-Positive Colorectal Carcinoma


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

ImClone LLC


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

102


Enrollment Type:

Actual


Overall Contact Information

Official Name:E-mail: ClinicalTrials@ ImClone.com
Study Chair
ImClone LLC

Study Dates

Start Date:March 2003
Completion Date:November 2005
Completion Type:Actual
Primary Completion Date:December 2004
Primary Completion Type:Actual
Verification Date:April 2010
Last Changed Date:April 8, 2010
First Received Date:June 4, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure:Compare overall survival in subjects with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-FU, and LV (FOLFOX4) and cetuximab with FOLFOX4 alone.
Time Frame:Every six weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Compare the response rates between the two treatment arms.
Time Frame:Every six weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Compare progression-free survival between the two treatment arms.
Time Frame:Every six weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Duration of response within each treatment arm.
Time Frame:Every six weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to response within each treatment arm.
Time Frame:Every six weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Compare the safety profiles between the two treatment arms.
Time Frame:Every six weeks
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Compare the quality of life (QOL)between the two treatment arms.
Time Frame:Every six weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Conduct an economic assessment comparing healthcare resource utilization between the two treatment arms.
Time Frame:Every six weeks
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:cetuximab
Description:400 mg/m2 IV
Arm Name:Cetuximab+FOLFOX4
Other Name:Erbitux™
Intervention Type:Drug
Name:oxaliplatin
Description:85 mg/m2 IV
Arm Name:Cetuximab+FOLFOX4
Other Name:Eloxatin®
Intervention Type:Drug
Name:leucovorin
Description:200 mg/m2 IV
Arm Name:Cetuximab+FOLFOX4
Other Name:Wellcovorin®
Intervention Type:Drug
Name:5-fluorouracil
Description:400 mg/m2 IV
Arm Name:Cetuximab+FOLFOX4
Other Name:5-FU
Intervention Type:Drug
Name:5-fluorouracil
Description:600 mg/m2 IV
Arm Name:Cetuximab+FOLFOX4
Other Name:5-FU
Intervention Type:Biological
Name:cetuximab
Description:250 mg/m2 IV
Arm Name:Cetuximab+FOLFOX4
Other Name:Erbitux™

Study Arms

Study Arm Type:Experimental
Arm Name:Cetuximab+FOLFOX4
Description:Day 1 - cetuximab loading dose of 400 mg/m2 IV, infused over 2 hours; oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion Day 8 - cetuximab maintenance dose of 250 mg/m2 IV infused over 60 minutes
Study Arm Type:Active Comparator
Arm Name:FOLFOX4.
Description:Day 1 - oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion. Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:ImClone LLC
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Bristol-Myers Squibb

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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