Clinical Trial: Study of Oxaliplatin, Irinotecan, and S-1 in Biliary Tract Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase II Study of S-1 in Combination With Oxaliplatin and Irinotecan in Patients With Advanced, Recurrent or Metastatic Biliary Tract Cancer

Brief Summary: This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan, and S-1 as the first-line chemotherapy in patients with advanced biliary tract cancer.

Detailed Summary:

It is widely accepted that the efficacy of chemotherapy for patients with inoperable, advanced, and metastatic biliary tract cancer is better than that compared to best supportive care. In general, gemcitabine based combination chemotherapies are considered as the first line treatment for patients with advanced biliary tract cancer, but these have some limitations of inconvenience of administration and unsatisfactory efficacy.

S-1 monotherapy and combination with oxaliplatin have shown the objective response rate of 21-35% and 24.5%, respectively, and irinotecan combined with oxaliplatin has shown the response rate of 18-20.5% in patients with advanced metastatic biliary tract cancer. So the investigators had conducted the phase I study of three drugs (oxaliplatin, irinotecan, and S-1) with modification of dosage and schedule and will conduct a phase II study with recommended dose of triple chemotherapy from this phase I study.


Sponsor: Hallym University Medical Center

Current Primary Outcome: overall response rate [ Time Frame: 1.5 year ]

Tumor response will be classified on the basis of the response evaluation criteria in solid tumors (RECIST) guidelines version 1.1


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • progression free survival [ Time Frame: 1.5 year ]
    The progression-free survival (PFS) will be measured from the start of study treatment until documented tumor progression (by RECIST) or death due to any cause
  • overall survival [ Time Frame: 1.5 year ]
    The overall survival (OS) will be estimated from the start of study treatment until participant's death and measured using the Kaplan-Meier method
  • toxicity profiles - the number of participants and grade of intensity of treatment related adverse events [ Time Frame: 1.5 year ]
    adverse events will be graded using the NCI common terminology criteria for adverse events (NCTCAE) v 4.0


Original Secondary Outcome: Same as current

Information By: Hallym University Medical Center

Dates:
Date Received: August 14, 2015
Date Started: March 2015
Date Completion: March 2017
Last Updated: September 27, 2016
Last Verified: September 2016