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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01494363
Recruitment Status : Unknown
Verified December 2011 by Nam Su Lee, Soon Chun Hyang University.
Recruitment status was:  Recruiting
First Posted : December 19, 2011
Last Update Posted : December 19, 2011
Information provided by (Responsible Party):
Nam Su Lee, Soon Chun Hyang University

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 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

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: Fluorouracil Drug: Leucovorin Drug: Oxaliplatin Drug: Irinotecan Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Phase II Study of Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan (FOLFOXIRI) in Patients With Locally Advanced or Metastatic Biliary Tract Cancer
Study Start Date : October 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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
  • Drug: Leucovorin
    Leucovorin 400 mg/m2 (diluted in 250 ml of 5% dextrose solution) as a 2-hour intravenous infusion every 2 weeks
  • Drug: Oxaliplatin
    Oxaliplatin 85 mg/m2 (diluted in 250 ml of 5% dextrose solution) given as a 2-hour intravenous infusion every 2 weeks
  • Drug: 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

Primary Outcome Measures :
  1. Response rate [ Time Frame: 2 years ]
    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 :
  1. Treatment-related toxicities [ Time Frame: 2 years ]
    Assessment of toxicity will be assessed according to NCI CTCAE version 4.0.

  2. Progression free survival [ Time Frame: 2 years ]
  3. Overall survival [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01494363

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Korea, Republic of
Hyun Jung Kim Recruiting
Bucheon, Korea, Republic of
Contact: Hyun Jung Kim, M.D.    +82-32-621-5114   
Han Jo Kim Recruiting
Cheonan, Korea, Republic of
Contact: Han Jo Kim, M.D.    +82-41-570-3693   
Nam Su Lee Recruiting
Seoul, Korea, Republic of
Contact: Nam Su Lee, M.D.    +82-2-709-9114   
Sponsors and Collaborators
Soon Chun Hyang University

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Responsible Party: Nam Su Lee, Professor, Soon Chun Hyang University Identifier: NCT01494363     History of Changes
Other Study ID Numbers: SCH01
First Posted: December 19, 2011    Key Record Dates
Last Update Posted: December 19, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs