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

NCT01494363 | Unknown Phase 2

• 1 other identifier: SCH01
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 3

Brief Summary

1. 1.Goals
2. 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

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Treatment-related toxicities

  2 years

• Progression free survival

  2 years

• Overall survival

  2 years

Interventions

Fluorouracil DRUG

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 DRUG

Leucovorin 400 mg/m2 (diluted in 250 ml of 5% dextrose solution) as a 2-hour intravenous infusion every 2 weeks

Oxaliplatin DRUG

Oxaliplatin 85 mg/m2 (diluted in 250 ml of 5% dextrose solution) given as a 2-hour intravenous infusion every 2 weeks

Irinotecan DRUG

Irinotecan 150 mg/m2 (diluted in 250 ml of 0.9% normal saline solution) given as a 90-minute intravenous infusion every 2 weeks

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Soon Chun Hyang University: lead

Study Sites (3)

Hyun Jung Kim

Bucheon-si, South Korea

RECRUITING

Han Jo Kim

Cheonan, South Korea

RECRUITING

Nam Su Lee

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Fluorouracil; Leucovorin; Oxaliplatin; Irinotecan

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 19, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 19, 2011

Record last verified: 2011-12

Locations

KR (3)