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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Soon Chun Hyang University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Nam Su Lee, Soon Chun Hyang University
ClinicalTrials.gov Identifier:
NCT01494363
First received: December 13, 2011
Last updated: December 14, 2011
Last verified: December 2011
  Purpose
  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 Intervention Phase
Biliary Tract Cancer
Drug: Fluorouracil
Drug: Leucovorin
Drug: Oxaliplatin
Drug: Irinotecan
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Soon Chun Hyang University:

Primary Outcome Measures:
  • Response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessment of toxicity will be assessed according to NCI CTCAE version 4.0.

  • Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 53
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494363

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

No publications provided

Responsible Party: Nam Su Lee, Professor, Soon Chun Hyang University
ClinicalTrials.gov Identifier: NCT01494363     History of Changes
Other Study ID Numbers: SCH01
Study First Received: December 13, 2011
Last Updated: December 14, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Fluorouracil
Oxaliplatin
Irinotecan
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014