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Gemcitabine-UFTE Chemotherapy in Refractory Colorectal Cancer

NCT01409005 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2014-02-11

No results posted yet for this study

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.

Conditions

  • Metastatic or Recurrent Colorectal Cancer
  • Refractory to Fluoropyrimidine, Oxaliplatin and Irinotecan
  • Salvage Chemotherapy

Interventions

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

Sponsors & Collaborators

  • Seoul National University Hospital

    collaborator OTHER

  • SMG-SNU Boramae Medical Center

    collaborator OTHER

  • Yuhan Pharmaceutical Company

    collaborator UNKNOWN

  • Jeil Pharmaceutical Company

    collaborator UNKNOWN

  • Seoul National University Bundang Hospital

    lead OTHER

Principal Investigators

  • Jee Hyun Kim, M.D. & Ph.D. · Professor, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-02-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01409005 on ClinicalTrials.gov