J1214, A multi-institutional open label, trial evaluating the efficacy of Gemcitabine and Docetaxel in patients with relapsed or refractory metastatic colorectal adenocarcinoma with methylated CHFR and/or microsatellite instability phenotype
Johns Hopkins Kimmel Cancer Center in Baltimore
Determine the efficacy of combination gemcitabine and docetaxel chemotherapy in the treatment of metastatic colorectal cancer with CHFR and/or MSI phenotype
-Adults with histologically documented metastatic colorectal adenocarcinoma with methylated CHFR and/or microsatellite instability phenotype that have relapsed or are refractory to one or more line(s) of standard therapy-Patients must be off prior chemotherapy, radiation therapy, hormonal therapy, or biological therapy for at least 4 weeks.-ECOG performance status 0 or 1-Adequate organ and marrow function
Patients will receive intravenous gemcitabine 800mg/m2 on days 1 and 8 and docetaxel 60mg/m2 on day 8 of each 21 day cycle. Patients will receive filgrastim (G-CSF) on days 9 through 15 or pegfilgrastim 6mg on day 9 or 10 of each cycle. Patients will be evaluated for toxicity prior to receiving each cycle and every 6 weeks for response using RECIST criteria 1.0.
07/31/2015 09:39 AM