Unresectable or recurrent biliary tract cancer
Conditions
Interventions
Sponsors
Kyorin University, School of Medicine
National Cancer Center Hospital, National Cancer Center Hospital East, Cancer Institute Hospital, Graduate School of Medicine, University of Tokyo, Kanagawa Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as biliary tract cancer which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer 2) Recurrent or unrespectable biliary tract cancer 3) Histologically proven papillary adenocarcinoma, tubular adenocarcinoma, or adenosquamous carcinoma for extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer patients. Histologically proven adenocarcinoma for intrahepatic cholangiocarcinoma 4) Progressive disease under gemcitabine-based chemotherapy or discontinuation of gemcitabine-based chemotherapy due to adverse events 5) Sufficient oral intake 6) Evidence of unidimensionally measurable disease 7) Without CNS metastasis 8) Without moderate or more ascites/pleural effusion 9) Life expectancy of 12 weeks or more 10) More than 2 weeks between the last administration of the prior chemotherapy regimen and study entry 11) 20 or more years of age 12) Eastern Cooperative Oncology Group performance status 0-1 13) Tumor specimens are available for biomaker analysis 14) No evidence of preexisting uncontrolled hypertension. Patients whose hypertension is controlled by antihypertensive therapies are eligible 15) Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to treatment 16) Adequate organ function 17) Written informed consent 18) Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Exclusion criteria
Exclusion criteria: 1) Simultaneous or metachronous (within 2 years) double cancers, with the exception of intramucosal tumor curable with local therapy 2) Active diverticulitis 3) Major surgery <4 weeks of starting the study treatment 4) Radiation therapy <2 weeks of starting the study treatment 5) A serious gastrointestinal disorder - Poor oral intake - Need intravenous nutrition - Malabsorption syndorome - After total gastrectomy - Active bleeding or past bleeding from gastrointestinal tract - Gastrointestinal involvement of cancer 6) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant 7) Psychosis or severe mental disorder 8) Complications such as myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism, within the 12 months prior to study drug administration 9) Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis 10) Active infection except hepatitis B or C virus 11) Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness 12) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, uncontrollable diabetes millitus etc 13) Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors 14) Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers 15) Requirement of anticoagulant therapy with oral vitamin K antagonists 16) Patients who can't receive neither iodic drug nor gadolinium because of drug allergy 17) Inadequate physical condition, as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| toxicity, objective response rate, overall survival and biomarkers at the baseline | — |
Countries
Japan
Contacts
Public ContactNaohiro Okano
Kyorin University, School of Medicine Department of Medical Oncology
Outcome results
None listed