NCT02527824

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: Hallym University Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Biliary Tract Neoplasm

Interventions

Type	Name	Description
DRUG	Oxaliplatin, Irinotecan, S-1	Treatment will be delivered every 2 weeks 1. Oxaliplatin 65 mg/m2 iv on day 1 2. Irinotecan 135 mg/m2 iv on day 1 3. S-1 80 mg/m2/day on day1-7

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-08-01
• Completion: 2017-09-01
• First posted: 2015-08-19
• Last updated: 2017-08-23

Locations

1 site across 1 country: South Korea