XELOX in Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy

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 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

NCT ID

NCT02350686

Organization ID

2014-09-020

Responsible Party

Principal Investigator

Study Sponsor

Samsung Medical Center

Study Sponsor

, , 

Verification Date

May 2019