Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Intervention: Bevacizumab; Cetuximab; 5-fluorouracil; Leucovorin; Oxaliplatin
Intervention description: 5 mg/kg IV; 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8; 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient); 350 mg IV; 85 mg/m2 IV
Intervention MeSH terms: Leucovorin; Bevacizumab; Cetuximab; Fluorouracil; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colon Cancer

Summary:

      This trial will evaluate the combination of modified infusional 5-fluorouracil/ leucovorin,
      oxaliplatin (FOLFOX6), bevacizumab, and cetuximab in patients with metastatic colorectal
      cancer. FOLFOX6 has proven to be a safe and effective regimen in first line treatment of
      advanced colorectal cancer. The role of epidermal growth factor (EGFR) inhibitors in an
      earlier treatment setting in combination with optimal chemotherapy regimens is an important
      emerging question.
    

Eligibility criteria:

        Inclusion Criteria:

        To be included in the study, you must meet the following criteria:

          -  Metastatic colorectal cancer confirmed by a biopsy sample

          -  18 years of age or older

          -  Evidence of disease progression at time of study entry

          -  At least one prior adjuvant chemotherapy regimen

          -  No prior therapy for metastatic disease

          -  Measurable disease

          -  Able to perform activities of daily living with minimal assistance

          -  Adequate bone marrow, kidney, and liver function

          -  Tumor tissue available for assessment of EGFR

          -  Signed informed consent

        Exclusion Criteria:

        You cannot participate in the study if any of the following apply to you:

          -  Treatment with a previous regimen for metastatic disease

          -  Prior treatment with any EGFR inhibitor or anti-angiogenic agents

          -  Brain or nervous system metastases

          -  History of severe thromboembolic event

          -  Clinical evidence or history of bleeding or coagulopathy

          -  History of stroke or heart attack within six months

          -  Poorly controlled hypertension

          -  Non-healing wound, ulcer, or bone fracture

          -  History of abdominal fistula, perforation, or abscess within six months

          -  Other uncontrolled or significant disease or medical condition

        Please note: There are additional inclusion/exclusion criteria. The study center will
        determine if you meet all of the criteria. If you do not qualify for the trial, study
        personnel will explain the reasons. If you do qualify, study personnel will explain the
        trial in detail and answer any questions you may have. You can then decide if you wish to
        participate.