Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Colorectal Cancer

Phase II, Multi-Center, Open-Label, Prospective Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type KRAS Colorectal Cancer Who Are Considered Nonoptimal Candidates or Are Intolerant to a First-Line Oxaliplatin/Irinotecan Regimen

The combination of capecitabine and cetuximab as first-line therapy will result in improved progression free survival compared to single agent capecitabine in patients with KRAS wild type colorectal cancer. Patients who are not able or willing to take Oxaliplatin/Irinotecan combination therapy are eligible for this study.

Inclusion Criteria

• Metastatic colorectal cancer

• Tumor classified WT KRAS

• At least 18 yrs of age

• ECOG PS 0,1 or 2

• Evidence of adequate organ function

• Measurable disease per RECIST criteria

• Have at least two of the following criteria:

  • Age > 65 years
  • ECOG PS 1 or 2
  • Serum Albumin < or equal to 3.5g/dL
  • Prior RT to abdomen or pelvis
  • Stopped first-line combination systemic chemotherapy < 6 weeks duration

Exclusion Criteria

• Tumors classified as KRAS mutation
• Prior therapy with cetuximab, panitumumab or other agent that targets EGFR
• Prior exposure to any biologic
• Known sensitivity to cetuximab or 5-FU (or marked intolerance to 5-FU)
• Known DPD deficiency
• Uncontrolled angina or a myocardial infarction within the previous 12 months
• Concurrent severe uncontrolled medical illness
• Known uncontrolled CNS metastases
• Bowel disease associated with chronic diarrhea
• Major surgery within 28 days