None listed
Conditions
Interventions
Drug : Pemetrexed: 500 mg/m210-minutes iv on day 1 every 3 weeks up to Progression disease
Oxalipaltin: 120 mg/m2 as 2-hour iv on day 1 every 3 weeks up to Progression disease
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Capable of understanding and complying with the protocol requirements and signed informed consent 2) Adults over 19 years old 3) Histologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, gallbladder carcinoma or ampullar of vater cancer) 4) Locally advanced unresectable, recurrence after curative surgery or metastatic disease 5) Progressive metastatic biliary tract cancer that cannot be operated after failing treatment with gemcitabine and cisplatin 6) ECOG performance capability status 0~1 7) Normal organ and bone marrow function 8) At least one measurable (per Response Evaluation Criteria in Solid Tumor [RECIST] 1.1) lesion 9) Patients must have a life expectancy = 3 month 10) A person who understands the contents of the clinical trial, is cooperative with the progress of the trial, and is judged to be able to participate until the end of the study 11) Evidence of postmenopausal or inability to conceive in women of childbearing potential 12) Male patients must use condoms during therapy and for 6 months after the last chemotherapy if they have sex with pregnant women or women of childbearing potential.
Exclusion criteria
Exclusion criteria: 1) Female patients who are pregnant or breastfeeding 2) Patients who have received chemotherapy with previous pemetrexed or oxaliplatin 3) one measurable lesion, those who have received radiation therapy for that lesion. 4) Uncontrolled central nervous system metastasis 5) Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia and vitiligo 6) Diagnosed with another malignancy in the past 2 years. 7) Pemetrexed (mannitol, hydrochloric acid, sodium hydroxide) 8) Serious medical-surgical or psychiatric conditions and medical conditions . 9) Other severe acute illness, or chronic medical or psychiatric disorder 10) Patients judged by the investigator to be inappropriate 11) Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 21 days of registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression;Overall survival;Safety profiles by NCI-CTCAE version 5 | — |
Countries
Korea, Republic of
Contacts
Public ContactInkeun Park
Asan Medical Center
Outcome results
None listed