Pemetrexed is a multitargeted antifolate, which primarily inhibits thymidylate synthase, dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase in the folate-dependent metabolic process. Nowadays, pemetrexed is used to treat malignant pleural mesothelioma and non-squamous non-small cell lung cancer. Preclinical and clinical studies showed that pemetrexed had cytotoxic activity in many kinds of cancers including colorectal cancer. Erlotinib is a tyrosine-kinase inhibitor of EGFR, which was approved for the treatment of non-small cell lung cancer. Erlotinib also showed activity to colorectal cancer cells. Recently, Zhang et al. demonstrated synergistic cytotoxicity of pemetrexed and gefitinib in preclinical study. In this multicenter, non randomized, open label phase II study, investigators aimed to evaluate the efficacy and safety of Pemetrexed and Erlotinib combination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Pemetrexed 500 mg/m2 IV over 10 minutes on day 1 every 21 days
Erlotinib 150 mg PO once daily on days 1-21 every 21 days
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Overall response rate
Time frame: up to 2 years
Progression-free survival
Time frame: up to 2 years
Overall survival
Time frame: up to 2 years
Disease control rate
Time frame: up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 2 years
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