Gemcitabine-UFTE Chemotherapy in Refractory Colorectal Cancer
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Seoul National University Bundang Hospital
Collaborators:
Jeil Pharmaceutical Company Seoul National University Hospital SMG-SNU Boramae Medical Center Yuhan Pharmaceutical Company