Metastatic or Recurrent Colorectal Cancer Clinical Trial
Official title:
A Phase II Trial of Gemcitabine Plus UFTE Combination Chemotherapy as Salvage Treatment in Oxaliplatin, Irinotecan and Fluoropyrimidine-Refractory Metastatic Colorectal Cancer
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment