None listed
Conditions
Interventions
Drug : 1. Control arm
gemcitabine plus cisplatin every 3 weeks, 9 cycles
- Cisplatin IV 25mg/m2 D1, 8
- Gemcitabine IV 1,000 mg/m2 IV D1, 8
2. Experimental arm
gemcitabine, cisplatin, and Genexol®PM
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients between 19 and 79 years old - Cytologically or histologically confirmed adenocarcinoma of biliary tract (gallbladder, intrahepatic, and extrahepatic bile ducts) with or without measurable lesion according to RECIST version 1.1 - Locally advanced unresectable, initially metastatic, and recurred disease - At least one or more evaluable lesions without prior radiotherapy - Patients with or without prior external or internal biliary drainage procedure (e.g., percutaneous transhepatic biliary drainage, endoscopic retrograde biliary drainage) - No previous chemotherapy except adjuvant chemotherapy with fluoropyrimidine-based regimen which completed 6 months or before - Eastern Cooperative Oncology Group (ECOG) performance status 0 ~ 2 - Adequate bone marrow function as defined by platelets = 100 x 109/L and neutrophils = 1.5 x 109/L - Adequate renal function, with serum creatinine 5 years previously without evidence of relapse - Written informed consent to the study
Exclusion criteria
Exclusion criteria: - Age=80 years - Histologically diagnosed adenosquamous carcinoma - AoV cancer - History of severe neurologic disorder or psychiatric disorder - Radiation therapy taken within 4 weeks - Gastrointestinal obstruction - Severe gastrointestinal bleeding - Medical history with coronary angioplasty, stent insertion, bypass within 6months - Myocardial infarction or other clinically significant heart disease within 6 months of initiation of the study treatment - High risk of cardiovascular conditions (including patients with recent coronary stent implantations, with myocardial infarction within 6 months, and with arrhythmia with unstable symptoms) - Past or present history of uncontrolled HIV, uncontrolled hepatitis B or C (in case of chronic hepatitis B or HBV carrier, HBV DNA level should be lower than 200IU/mL) - Severe and/or uncontrolled medical conditions which may interfere with participation in the study, including significant active or uncontrolled infection (bacterial, viral, and fungal infection) - Allergy or hypersensitivity reaction to paclitaxel, gemcitabine, cisplatin, or Cremophor EL; patients with symptoms in Contraindications and Precautions - Patients with genetic problems including galactose intolerance, lapp lactose deficiency or glucose-galactose malabsorption - interstitial pneumonitis or pulmonary fibrosis clearly visible on the x-ray with clinical symptoms - Hearing impairment - Cisplatin-induced neuropathy - Other serious diseases or medical conditions - Pregnant or lactating women or women of childbearing potential who do not consider appropriate contraceptives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (be evaluated by the site investigators);Objective response rate to RECIST(Response evaluation criteria in solid tumors) guidelines;Safety profile;Progression-free survival (be evaluated by the independent reviewer) | — |
Countries
Korea, Republic of
Contacts
Public ContactYounglan Hong
Asan Medical Center
Outcome results
None listed