Phase II Study of FOLFOXIRI in Patients With Locally Advanced or Metastatic Biliary Tract Cancer

Biliary Tract Cancer Clinical Trial

Official title:

Multicenter Phase II Study of Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan (FOLFOXIRI) in Patients With Locally Advanced or Metastatic Biliary Tract Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01494363
• Other study ID #: SCH01
• Status: Recruiting
• Phase: Phase 2
• First received: December 13, 2011
• Last updated: December 14, 2011
• Start date: October 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2011
• Source: Soon Chun Hyang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 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

2. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients who were diagnosed as adenocarcinoma of gallbladder or biliary tract histologically or cytologically

2. Unresectable locally advanced, metastatic, or recurrent biliary tract cancer

3. Patients must be = 18 , = 75 years old of age

4. ECOG performance status = 2

5. At least one lesion that can be measured by imaging (CT/MRI) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

6. Estimated life expectancy of more than 3 months

7. 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)

8. Adequate kidney function (serum creatinine < 1.5 x upper limit of normal [ULN])

9. Adequate liver function (serum total bilirubin < 3.0xULN; serum transaminases levels < 5.0xUNL)

10. Provision of fully informed consent prior to any study specific procedures

Exclusion Criteria:

1. Other tumor type than adenocarcinoma

2. 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)

3. 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)

4. Patients who received radiotherapy on target lesion within 6 months prior to study treatment

5. Patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases

6. Patients who received major surgery within 4 weeks of starting study treatment or was not recovered from any effects of major surgery

7. Pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception

8. 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

9. Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• Fluorouracil
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
• Leucovorin
Leucovorin 400 mg/m2 (diluted in 250 ml of 5% dextrose solution) as a 2-hour intravenous infusion every 2 weeks
• Oxaliplatin
Oxaliplatin 85 mg/m2 (diluted in 250 ml of 5% dextrose solution) given as a 2-hour intravenous infusion every 2 weeks
• Irinotecan
Irinotecan 150 mg/m2 (diluted in 250 ml of 0.9% normal saline solution) given as a 90-minute intravenous infusion every 2 weeks

Locations

Country	Name	City	State
Korea, Republic of	Hyun Jung Kim	Bucheon
Korea, Republic of	Han Jo Kim	Cheonan
Korea, Republic of	Nam Su Lee	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Soon Chun Hyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years	No
Secondary	Treatment-related toxicities	Assessment of toxicity will be assessed according to NCI CTCAE version 4.0.	2 years	No
Secondary	Progression free survival		2 years	No
Secondary	Overall survival		2 years	No