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

Samsung Medical Center logo

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)

67 participants in 1 patient group

capecitabine+oxaliplatin
Experimental group
Description:
XELOX every 3 weeks
Treatment:
Drug: oxaliplatin
Drug: capecitabine

Trial contacts and locations

1

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Central trial contact

hoyeong lim, MD,Ph; sungju park

Data sourced from clinicaltrials.gov

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