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
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).
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression-free survival
Secondary Outcome
response rate
Condition
Biliary Tract Cancer
Intervention
capecitabine
Study Arms / Comparison Groups
capecitabine+oxaliplatin
Description: XELOX every 3 weeks
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
67
Start Date
May 14, 2015
Completion Date
December 2020
Primary Completion Date
December 2019
Eligibility Criteria
Inclusion Criteria: 1. age ≥ 18 2. histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer and ampulla of Vater cancer) 3. unresectable or metastatic 4. progression after treatment with first line gemcitabine-based chemotherapy 5. ECOG performance status of 0~2 6. measurable or evaluable lesion per RECIST 1.1 criteria 7. adequate marrow, hepatic, renal and cardiac functions Exclusion Criteria: 1. severe co-morbid illness or active infections 2. pregnant or lactating women 3. 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 4. active CNS metastases not controllable with radiotherapy or corticosteroids 5. known history of hypersensitivity to study drugs
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, , [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT02350686
Organization ID
2014-09-020
Responsible Party
Principal Investigator
Study Sponsor
Samsung Medical Center
Study Sponsor
, ,
Verification Date
May 2019