Study of Cetuximab, Oxaliplatin, 5-FU/LV Versus Oxaliplatin, 5-FU/LV in Patients With Previously Treated Metastatic, EGFR-Positive Colorectal Cancer
This study has been completed.
Sponsor:
ImClone LLC
Collaborator:
Bristol-Myers Squibb
Information provided by:
ImClone LLC
ClinicalTrials.gov Identifier:
NCT00061815
First received: June 4, 2003
Last updated: April 8, 2010
Last verified: April 2010
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Biological: cetuximab Drug: oxaliplatin Drug: leucovorin Drug: 5-fluorouracil |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Fluorouracil
Leucovorin calcium
Oxaliplatin
Levoleucovorin
Cetuximab
U.S. FDA Resources
Further study details as provided by ImClone LLC:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Compare the response rates between the two treatment arms. [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]
- Compare progression-free survival between the two treatment arms. [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]
- Duration of response within each treatment arm. [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]
- Time to response within each treatment arm. [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]
- Compare the safety profiles between the two treatment arms. [ Time Frame: Every six weeks ] [ Designated as safety issue: Yes ]
- Compare the quality of life (QOL)between the two treatment arms. [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]
- Conduct an economic assessment comparing healthcare resource utilization between the two treatment arms. [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]
| Enrollment: | 102 |
| Study Start Date: | March 2003 |
| Study Completion Date: | November 2005 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
Experimental: Cetuximab+FOLFOX4
|
Biological: cetuximab
400 mg/m2 IV
Other Name: Erbitux™
Drug: oxaliplatin
85 mg/m2 IV
Other Name: Eloxatin®
Drug: leucovorin
200 mg/m2 IV
Other Name: Wellcovorin®
Drug: 5-fluorouracil
400 mg/m2 IV
Other Name: 5-FU
Drug: 5-fluorouracil
600 mg/m2 IV
Other Name: 5-FU
Biological: cetuximab
250 mg/m2 IV
Other Name: Erbitux™
|
Active Comparator: FOLFOX4.
|
Drug: oxaliplatin
85 mg/m2 IV
Other Name: Eloxatin®
Drug: leucovorin
200 mg/m2 IV
Other Name: Wellcovorin®
Drug: 5-fluorouracil
400 mg/m2 IV
Other Name: 5-FU
Drug: 5-fluorouracil
600 mg/m2 IV
Other Name: 5-FU
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061815
Show 39 Study Locations
Show 39 Study LocationsSponsors and Collaborators
ImClone LLC
Bristol-Myers Squibb
Investigators
| Study Chair: | E-mail: ClinicalTrials@ ImClone.com | ImClone LLC |
More Information
No publications provided
| Responsible Party: | Chief Medical Officer, ImClone LLC |
| ClinicalTrials.gov Identifier: | NCT00061815 History of Changes |
| Obsolete Identifiers: | NCT00065520 |
| Other Study ID Numbers: | CA225-014 |
| Study First Received: | June 4, 2003 |
| Last Updated: | April 8, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fluorouracil Oxaliplatin Cetuximab Leucovorin |
Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes |
ClinicalTrials.gov processed this record on May 16, 2013