Although there have been remarkable advances in the treatment of metastatic or recurrent colorectal cancer (MRCRC), long term survival cannot be expected in most patients with MRCRC because of inevitably developing resistance to chemotherapeutic drugs except some MRCRC patients who can undergo complete resection (metastasectomy). Until now, approved cytotoxic drugs for treatment of MCRC are only 3 categories (fluoropyrimidine, oxaliplatin and irinotecan). Recently, molecularly targeted drugs are approved for MRCRC patients, and bevacizumab and cetuximab (for K-ras wild type tumors) are available. When cytotoxic and targeted drugs are appropriately combined, about 24 months of overall survival (OS) can be expected in patients with MRCRC. However, when these drugs are all used or patients cannot afford to receive expensive targeted drugs because of economical problems, there is no option for chemotherapy and best supportive care is the only option, although some patients still have good performance status and medical conditions. Therefore, there are unmet needs for additional salvage chemotherapy regimens for patients with oxaliplatin, irinotecan and fluoropyrimidine-refractory MRCRC. In some previous studies, gemcitabine-based chemotherapy showed some antitumor activities in MRCRC patients. Especially, when combined with fluoropyrimidine, gemcitabine has been shown to exert synergic effects on antitumor activities. On these backgrounds, this phase 2 clinical study was designed. In this study, efficacy and safety of gemcitabine plus UFTE chemotherapy will be evaluated in MRCRC patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Gemcitabine : 800 mg/m2 mix with 150mL of normal saline (i.v.) over 30 min on Days 1, 8 and 15 UFTE : 200mg/m2 PO q 8 hr, Days 1\~21 Interval: every 4 weeks
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, Seoul, South Korea
8-weeks progression free survival rate (PFS rate)
% of patients without tumor prgression at 8 weeks after the initiation of chemotherapy
Time frame: Response evaluation using computed tomography (CT) at 8 weeks after the initiation of chemotherapy
Overall survival (OS)
OS will be measured until death of patients or study completion. Survival status will be followed up every 3 months if study treatment is completed.
Time frame: OS will be measured until death or study completion, with an expected average of 9 months
Response rate (RR)
RECIST version 1.1 will be used for response evaluation
Time frame: Response evaluation using CT will be performed every 8 weeks until tumor progression or death
Percentage of Patients with Adverse Events
Hematologic and non-hematologic toxicities will be evaluated.
Time frame: Overall safety will be monitored on every visit of patients during chemotherapy, with an expected average of 4 months
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