Biliary Tract Cancer
Conditions
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).
Interventions
DRUGcapecitabine
XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles
DRUGoxaliplatin
XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | 12months |
Secondary
| Measure | Time frame |
|---|---|
| response rate | 12months |
| duration of response | 12months |
| overall survival | 12months |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 24months |
Countries
South Korea
Contacts
Primary Contacthoyeong lim, MD,Ph
Backup Contactsungju park
Outcome results
None listed