Gemcitabine-UFTE Chemotherapy in Refractory 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.
|Metastatic or Recurrent Colorectal Cancer Refractory to Fluoropyrimidine, Oxaliplatin and Irinotecan Salvage Chemotherapy||Drug: Gemcitabine and UFTE chemotherapy||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Gemcitabine Plus UFTE Combination Chemotherapy as Salvage Treatment in Oxaliplatin, Irinotecan and Fluoropyrimidine-Refractory Metastatic Colorectal Cancer|
- 8-weeks progression free survival rate (PFS rate) [ Time Frame: Response evaluation using computed tomography (CT) at 8 weeks after the initiation of chemotherapy ]% of patients without tumor prgression at 8 weeks after the initiation of chemotherapy
- Overall survival (OS) [ Time Frame: OS will be measured until death or study completion, with an expected average of 9 months ]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.
- Response rate (RR) [ Time Frame: Response evaluation using CT will be performed every 8 weeks until tumor progression or death ]RECIST version 1.1 will be used for response evaluation
- Percentage of Patients with Adverse Events [ Time Frame: Overall safety will be monitored on every visit of patients during chemotherapy, with an expected average of 4 months ]Hematologic and non-hematologic toxicities will be evaluated.
|Study Start Date:||June 2011|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: Gemcitabine plus UFTE
Gemcitabine plus UFTE chemotherapy (Single arm)
Drug: Gemcitabine and UFTE chemotherapy
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409005
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam, Gyeonggi-do, Korea, Republic of, 463-707|
|Seoul National University Hospital|
|Seoul, Korea, Republic of|
|SMG-SNU Boramae Medical Center|
|Seoul, Korea, Republic of|
|Principal Investigator:||Jee Hyun Kim, M.D. & Ph.D.||Professor, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine|