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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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
Evergreen Hematology & Oncology
Spokane, Washington, United States
Primary objective is to assess PFS in patients with WT KRAS CRC treated with the combination regimen of capecitabine and cetuximab
Time frame: 18 months
To assess the response rate in patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab
Time frame: 18 months
To assess the overall survival rate among patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab
Time frame: 18 months
To characterize the toxic effects and AEs of the combination regimen of capecitabine and cetuximab in this patient population
Time frame: every three months
To perform exploratory analyses of serum and tumor biomarkers (EGFR mutations and genotyping) on toxicity and efficacy.
Time frame: 1 year after study closure
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