Overview

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

Status:
Unknown status
Trial end date:
2017-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hallym University Medical Center
Collaborator:
Jeil Pharmaceutical Co., Ltd.
Treatments:
Camptothecin
Irinotecan
Oxaliplatin
Tegafur
Criteria
Inclusion Criteria:

- Pathologically confirmed advanced, recurrent or metastatic adenocarcinoma of biliary
tract system (stage IV by primary tumor, regional nodes, metastasis(TNM) staging
system)

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- More than 3 months expected life span

- Measurable lesion by RECIST criteria version 1.1

- Palliative chemotherapy naive

- Adequate organ functions

- Participants must sign an informed consent indicating that they are aware of the
investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria:

- Any prior 2 years or concurrent malignancy other than non-melanoma skin cancer, in
situ cancer of uterine cervix, or papillary or follicular thyroid cancer.

- Participants who had received radiation therapy for target lesions 4 weeks before
study enrollment

- Participants who had received major surgery 4 weeks before study enrollment

- Participants with active infection, severe heart disease, uncontrollable hypertension
or diabetes mellitus, myocardial infarction during the preceding 12 months, pregnancy,
or breast feeding

- Participants with central nervous system(CNS) metastases

- Participants with peripheral sensory neuropathies with impaired functional activities

- Participants with gastrointestinal obstruction or bleeding inducing mal-absorption of
oral chemotherapeutic agents.