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

Samsung Medical Center

Status and phase: Unknown; Phase 2

Conditions: Biliary Tract Cancer

Treatments: Drug: capecitabine; Drug: oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02350686

2014-09-020

Details and patient eligibility

About

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

Full 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).

Enrollment: 67 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

capecitabine+oxaliplatin

Experimental group

Description:

XELOX every 3 weeks

Treatment:

Drug: oxaliplatin

Drug: capecitabine