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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: capecitabine and cetuximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: capecitabine and cetuximab|Cetuximab 500 mg/m2 IV infusion over 1-2 hours Once every 2 weeks Capecitabine 1500 mg/m2 PO BID Days 1-7 followed by 7 days of no treatment and repeated every 2 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary objective is to assess PFS in patients with WT KRAS CRC treated with the combination regimen of capecitabine and cetuximab |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the response rate in patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab |  | 18 months | 
| To assess the overall survival rate among patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab |  | 18 months | 
| To characterize the toxic effects and AEs of the combination regimen of capecitabine and cetuximab in this patient population |  | every three months | 
| To perform exploratory analyses of serum and tumor biomarkers (EGFR mutations and genotyping) on toxicity and efficacy. |  | 1 year after study closure |