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

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ClinicalTrials.gov Identifier: NCT02350686
Recruitment Status : Recruiting
First Posted : January 30, 2015
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Ho Yeong Lim, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: capecitabine Drug: oxaliplatin Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 14, 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: capecitabine+oxaliplatin
XELOX every 3 weeks
Drug: capecitabine
XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles
Other Name: xeloda

Drug: oxaliplatin
XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 12months ]

Secondary Outcome Measures :
  1. response rate [ Time Frame: 12months ]
  2. duration of response [ Time Frame: 12months ]
  3. overall survival [ Time Frame: 12months ]
  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350686


Contacts
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Contact: hoyeong lim, MD,Ph hoy.lim@samsung.com
Contact: sungju park sungju6820.park@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: sungju park       sungju6820.park@samsung.com   
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Ho Yeong Lim, MD, PhD, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02350686     History of Changes
Other Study ID Numbers: 2014-09-020
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs