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

Primary Purpose

Biliary Tract Neoplasm

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oxaliplatin, Irinotecan, S-1
Sponsored by
Hallym University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Neoplasm focused on measuring biliary tract neoplasm, oxaliplatin, irinotecan, S-1

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hallym university medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oxaliplatin, Irinotecan, S-1(OIS)

Arm Description

intervention with triple combination chemotherapy with oxaliplatin, irinotecan, and S-1 Treatment will be delivered as a 2-week cycle. Oxaliplatin 65 mg/m2 iv on day 1 Irinotecan 135 mg/m2 iv on day 1 S-1 80 mg/m2/day on day 1-7

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

progression free survival
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
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
adverse events will be graded using the NCI common terminology criteria for adverse events (NCTCAE) v 4.0

Full Information

First Posted
August 14, 2015
Last Updated
August 22, 2017
Sponsor
Hallym University Medical Center
Collaborators
Jeil Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02527824
Brief Title
Study of Oxaliplatin, Irinotecan, and S-1 in Biliary Tract Cancer
Official Title
Phase II Study of S-1 in Combination With Oxaliplatin and Irinotecan in Patients With Advanced, Recurrent or Metastatic Biliary Tract Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hallym University Medical Center
Collaborators
Jeil Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Neoplasm
Keywords
biliary tract neoplasm, oxaliplatin, irinotecan, S-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxaliplatin, Irinotecan, S-1(OIS)
Arm Type
Experimental
Arm Description
intervention with triple combination chemotherapy with oxaliplatin, irinotecan, and S-1 Treatment will be delivered as a 2-week cycle. Oxaliplatin 65 mg/m2 iv on day 1 Irinotecan 135 mg/m2 iv on day 1 S-1 80 mg/m2/day on day 1-7
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin, Irinotecan, S-1
Other Intervention Name(s)
Liplatin, Inotecan, TS-1(tegafur, gimeracil, oteracil)
Intervention Description
Treatment will be delivered every 2 weeks Oxaliplatin 65 mg/m2 iv on day 1 Irinotecan 135 mg/m2 iv on day 1 S-1 80 mg/m2/day on day1-7
Primary Outcome Measure Information:
Title
overall response rate
Description
Tumor response will be classified on the basis of the response evaluation criteria in solid tumors (RECIST) guidelines version 1.1
Time Frame
1.5 year
Secondary Outcome Measure Information:
Title
progression free survival
Description
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
Time Frame
1.5 year
Title
overall survival
Description
The overall survival (OS) will be estimated from the start of study treatment until participant's death and measured using the Kaplan-Meier method
Time Frame
1.5 year
Title
toxicity profiles - the number of participants and grade of intensity of treatment related adverse events
Description
adverse events will be graded using the NCI common terminology criteria for adverse events (NCTCAE) v 4.0
Time Frame
1.5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Young Zang, MD, PhD
Organizational Affiliation
Hallym University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym university medical center
City
Anyang
State/Province
Gyunggi
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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