Abstract
Standard weekly cetuximab and irinotecan is an effective regimen in heavily pre-treated patients with metastatic colorectal cancer. The aim of this study is to prospectively evaluate the efficacy of combination chemotherapy with biweekly cetuximab and irinotecan in patients with pre-treated metastatic colorectal cancer harboring wild-type KRAS. A total of 30 patients will be enrolled at four medical institutions. The primary endpoint is response rate. The secondary endpoints include adverse events, progression-free survival and overall survival. The pharmacokinetics of cetuximab will also be evaluated in five patients.
Publication types
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Clinical Trial, Phase II
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Multicenter Study
MeSH terms
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Antibodies, Monoclonal / administration & dosage
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Antibodies, Monoclonal / pharmacokinetics
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Antibodies, Monoclonal / therapeutic use*
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Antibodies, Monoclonal, Humanized
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Antineoplastic Combined Chemotherapy Protocols / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Camptothecin / administration & dosage
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Camptothecin / analogs & derivatives*
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Camptothecin / therapeutic use
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Cetuximab
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Clinical Protocols
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Colorectal Neoplasms / drug therapy*
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Colorectal Neoplasms / genetics
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Colorectal Neoplasms / pathology
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Disease-Free Survival
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Humans
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Irinotecan
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Neoplasm Metastasis
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Proto-Oncogene Proteins / genetics
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Proto-Oncogene Proteins p21(ras)
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ras Proteins / genetics
Substances
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Antibodies, Monoclonal
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Antibodies, Monoclonal, Humanized
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KRAS protein, human
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Proto-Oncogene Proteins
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Irinotecan
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Proto-Oncogene Proteins p21(ras)
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ras Proteins
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Cetuximab
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Camptothecin