Status:
UNKNOWN
Phase II Study of FOLFOXIRI in Patients With Locally Advanced or Metastatic Biliary Tract Cancer
Lead Sponsor:
Soon Chun Hyang University
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
1. Goals The primary goal of this phase II trial is to: evaluate the response rate of combination chemotherapy with Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan in patients with local...
Eligibility Criteria
Inclusion
- Patients who were diagnosed as adenocarcinoma of gallbladder or biliary tract histologically or cytologically
- Unresectable locally advanced, metastatic, or recurrent biliary tract cancer
- Patients must be ≥ 18 , ≤ 75 years old of age
- ECOG performance status ≤ 2
- At least one lesion that can be measured by imaging (CT/MRI) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- Estimated life expectancy of more than 3 months
- Adequate bone marrow function (absolute neutrophil count \[ANC\] ≥ 1,500/µL, hemoglobin ≥ 9.0 g/dL \[correction by transfusion is acceptable\], and platelets ≥ 100,000/µL)
- Adequate kidney function (serum creatinine \< 1.5 x upper limit of normal \[ULN\])
- Adequate liver function (serum total bilirubin \< 3.0xULN; serum transaminases levels \< 5.0xUNL)
- Provision of fully informed consent prior to any study specific procedures
Exclusion
- Other tumor type than adenocarcinoma
- Any previous history of chemotherapy for biliary tract cancer (prior neoadjuvant/adjuvant chemotherapy is allowed, if recurrence occurred more than 6 months after completion of previous chemotherapy)
- Patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years)
- Patients who received radiotherapy on target lesion within 6 months prior to study treatment
- Patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases
- Patients who received major surgery within 4 weeks of starting study treatment or was not recovered from any effects of major surgery
- Pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions A. Clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment \[NYHA class III or IV\], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 AV block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry B. Liver cirrhosis (≥ Child-Pugh class B) C. History of significant neurologic or psychiatric disorders including dementia or seizures D. Active uncontrolled infection E. Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
- Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01494363
Start Date
October 1 2011
End Date
December 1 2013
Last Update
December 19 2011
Active Locations (3)
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1
Hyun Jung Kim
Bucheon-si, South Korea
2
Han Jo Kim
Cheonan, South Korea
3
Nam Su Lee
Seoul, South Korea