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

Phase 2

• Conditions: Biliary Tract Cancer
• Interventions: Drug: capecitabine; Drug: oxaliplatin

• Registration Number: NCT02350686
• Lead Sponsor: 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.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2015-01-26
• Study First Posted: 2015-01-30
• Study Start: 2015-05-14
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-20
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 67

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
capecitabine+oxaliplatin	capecitabine	XELOX every 3 weeks
capecitabine+oxaliplatin	oxaliplatin	XELOX every 3 weeks

Primary Outcome Measures

Name	Time	Method
Progression-free survival	12months

Secondary Outcome Measures

Name	Time	Method
response rate	12months
duration of response	12months
overall survival	12months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	24months

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of