Phase II Study of FOLFOXIRI in Patients With Locally Advanced or Metastatic Biliary Tract Cancer
Primary Purpose
Biliary Tract Cancer
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fluorouracil
Leucovorin
Oxaliplatin
Irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Tract Cancer
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Hyun Jung KimRecruiting
- Han Jo KimRecruiting
- Nam Su LeeRecruiting
Outcomes
Primary Outcome Measures
Response rate
Assessment of response will be assessed according to RECIST v1.1 criteria after completion of every two cycles. Evaluation will be conducted by physical examination, X-ray, or CT scan
Secondary Outcome Measures
Treatment-related toxicities
Assessment of toxicity will be assessed according to NCI CTCAE version 4.0.
Progression free survival
Overall survival
Full Information
NCT ID
NCT01494363
First Posted
December 13, 2011
Last Updated
December 14, 2011
Sponsor
Soon Chun Hyang University
1. Study Identification
Unique Protocol Identification Number
NCT01494363
Brief Title
Phase II Study of FOLFOXIRI in Patients With Locally Advanced or Metastatic Biliary Tract Cancer
Official Title
Multicenter Phase II Study of Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan (FOLFOXIRI) in Patients With Locally Advanced or Metastatic Biliary Tract Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soon Chun Hyang University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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 locally advanced or metastatic Biliary tract cancer as first-line chemotherapy
Secondary goals are to:
evaluate the treatment-related toxicities of this combination, investigate progression-free survival(PFS) and overall survival(OS) in this population
Design The proposed clinical trial is an open label, non-comparative, multicenter phase II trial according to the two stage testing design by Simon two-stage testing procedure
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Intervention Description
5-fluorouracil 2400 mg/m2 (diluted in 1000 ml of 5% dextrose solution) administered as a continuous intravenous infusion over 48 hours every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
Leucovorin 400 mg/m2 (diluted in 250 ml of 5% dextrose solution) as a 2-hour intravenous infusion every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin 85 mg/m2 (diluted in 250 ml of 5% dextrose solution) given as a 2-hour intravenous infusion every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Irinotecan 150 mg/m2 (diluted in 250 ml of 0.9% normal saline solution) given as a 90-minute intravenous infusion every 2 weeks
Primary Outcome Measure Information:
Title
Response rate
Description
Assessment of response will be assessed according to RECIST v1.1 criteria after completion of every two cycles. Evaluation will be conducted by physical examination, X-ray, or CT scan
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Treatment-related toxicities
Description
Assessment of toxicity will be assessed according to NCI CTCAE version 4.0.
Time Frame
2 years
Title
Progression free survival
Time Frame
2 years
Title
Overall survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
Hyun Jung Kim
City
Bucheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun Jung Kim, M.D.
Phone
+82-32-621-5114
Email
khjbless@schmc.ac.kr
Facility Name
Han Jo Kim
City
Cheonan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Jo Kim, M.D.
Phone
+82-41-570-3693
Email
hzmd@schmc.ac.kr
Facility Name
Nam Su Lee
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nam Su Lee, M.D.
Phone
+82-2-709-9114
Email
mdnslee@schmc.ac.kr
12. IPD Sharing Statement
Learn more about this trial
Phase II Study of FOLFOXIRI in Patients With Locally Advanced or Metastatic Biliary Tract Cancer
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