A phase II clinical trial of PemetRexed plus Oxaliplatin in patients with advanced biliary tract cancer after failure of 1st line geMcitabine plus cisPlaTin based chemotherapy
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0008608
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 30
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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Time to progression;Overall survival;Safety profiles by NCI-CTCAE version 5