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

Biliary Tract Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02350686
• Other study ID #: 2014-09-020
• Status: Recruiting
• Phase: Phase 2
• Start date: May 14, 2015
• Est. completion date: December 2020

Study information

• Verified date: May 2019
• Source: Samsung Medical Center
• Contact: hoyeong lim, MD,Ph
• Email: hoy.lim[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase II study of second line capecitabine plus oxaliplatin (XELOX) in patients with advanced biliary tract carcinoma after failure of gemcitabine-based chemotherapy.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 67
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		12months
Secondary	response rate		12months
Secondary	duration of response		12months
Secondary	overall survival		12months
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		24months