Back to resultsXELOX in Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy
Primary Purpose
Biliary Tract Cancer
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
capecitabine
oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Tract Cancer
Eligibility Criteria
Inclusion Criteria:
- age ≥ 18
- histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer and ampulla of Vater cancer)
- unresectable or metastatic
- progression after treatment with first line gemcitabine-based chemotherapy
- ECOG performance status of 0~2
- measurable or evaluable lesion per RECIST 1.1 criteria
- adequate marrow, hepatic, renal and cardiac functions
Exclusion Criteria:
- severe co-morbid illness or active infections
- pregnant or lactating women
- History of documented congestive heart failure, angina pectoris requiring medication, evidence of tranasmural myocardial infarction on ECG, poorly controlled hypertension, clinically significant valvular heart disease or high risk of uncontrollable arrhythmia
- active CNS metastases not controllable with radiotherapy or corticosteroids
- known history of hypersensitivity to study drugs
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
capecitabine+oxaliplatin
Arm Description
XELOX every 3 weeks
Outcomes
Primary Outcome Measures
Progression-free survival
Secondary Outcome Measures
response rate
duration of response
overall survival
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02350686
Brief Title
XELOX in Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy
Official Title
Phase II Study of Second Line Capecitabine Plus Oxaliplatin (XELOX) in Patients With Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2015 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phase II study of second line capecitabine plus oxaliplatin (XELOX) in patients with advanced biliary tract carcinoma after failure of gemcitabine-based chemotherapy.
Detailed Description
XELOX
Xeloda, 1000mg/㎡ bid, day 1-15, every 3 weeks
Oxaliplatin 130mg/㎡, day 1, every 3 weeks Until disease progression, patient's refusal or up to 8 cycles (maximum).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
capecitabine+oxaliplatin
Arm Type
Experimental
Arm Description
XELOX every 3 weeks
Intervention Type
Drug
Intervention Name(s)
capecitabine
Other Intervention Name(s)
xeloda
Intervention Description
XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
12months
Secondary Outcome Measure Information:
Title
response rate
Time Frame
12months
Title
duration of response
Time Frame
12months
Title
overall survival
Time Frame
12months
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
24months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥ 18
histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer and ampulla of Vater cancer)
unresectable or metastatic
progression after treatment with first line gemcitabine-based chemotherapy
ECOG performance status of 0~2
measurable or evaluable lesion per RECIST 1.1 criteria
adequate marrow, hepatic, renal and cardiac functions
Exclusion Criteria:
severe co-morbid illness or active infections
pregnant or lactating women
History of documented congestive heart failure, angina pectoris requiring medication, evidence of tranasmural myocardial infarction on ECG, poorly controlled hypertension, clinically significant valvular heart disease or high risk of uncontrollable arrhythmia
active CNS metastases not controllable with radiotherapy or corticosteroids
known history of hypersensitivity to study drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hoyeong lim, MD,Ph
Email
hoy.lim@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
sungju park
Email
sungju6820.park@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sungju park
Email
sungju6820.park@samsung.com
12. IPD Sharing Statement
Learn more about this trial
XELOX in Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy
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