A Phase II Trial of Modified FOLFOX 6 and Cetuximab in First Line Treatment of Metastatic Colorectal Cancer

Completed · Phase 2

Conditions studied: Colorectal Cancer

In brief

This is a Phase II, open label, non-randomized study in patients with histologically or pathologically confirmed diagnosis of stage IIIB/IV, EGFR+ adenocarcinoma of the colon or rectum who have not received prior chemotherapy for their metastatic disease. Primary Study Endpoint: To assess the response rate, progression-free survival, and overall safety profile of a modified FOLFOX 6 plus cetuximab regimen in the first-line treatment of patients with metastatic colorectal cancer. Secondary Study Endpoint(s): To assess overall survival of patients with metastatic colorectal cancer who receive first-line therapy with a modified FOLFOX 6 + cetuximab regimen.

Key facts

Study ID

NCT00251485

Run by

Veeda Oncology

People needed

82

Starts

2004-03-01

Expected to finish

2005-06-01

Last updated by the study team

2008-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have signed an IRB approved informed consent.
• Patients with histologically or pathologically documented, stage IIIB or IV adenocarcinoma of the colon or rectum.
• Patients with disease that is not amenable to potentially curative resection (i.e., inoperable metastatic disease).
• Patients with tumors that are EGFR + by IHC staining.
• Patients with ECOG Performance status of 0 or 1.
• Patients, 18 years and older, must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal.
• Bone marrow function: absolute neutrophil count (ANC) > or = 1,500/uL, equivalent to Common Terminology Criteria for Adverse Events (CTCAE, version 3) Grade 1. Platelets > or = 100,000/uL (CTCAE Grade 0 - 1).
• Renal function: creatinine < or = 1.5 x institutional upper limit of normal (ULN), CTCAE Grade 1.
• Hepatic function: bilirubin < or = 1.5 x ULN, CTCAE Grade 1. AST < or = 2.5 x ULN, CTCAE Grade 1.

You may not qualify if…

• Patients who received prior chemotherapy for metastatic disease. Prior adjuvant therapy with 5FU/LV and/or irinotecan is allowed provided it was completed at least 6 months prior to enrollment in this study.
• Patents who received prior oxaliplatin.
• Patients who received prior cetuximab or other therapy which specifically and directly targets the EGF pathway.
• Patients with acute hepatitis.
• Patients with active or uncontrolled infection.
• Patients with a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, and congestive heart failure.
• Prior allergic reaction to chimerized or murine monoclonal antibody therapy.
• Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent.
• Patients with peripheral neuropathy > grade 1

Where it is running

• Veeda Oncology — Houston, Texas, United States

Full record on ClinicalTrials.gov

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