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FOLFIRINOX for 2nd-line Treatment of BTC

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03778593
Recruitment Status : Not yet recruiting
First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Information provided by (Responsible Party):
Sung Yong Oh, Dong-A University Hospital

Brief Summary:
Biliary tract cancer (BTC) is rare in the West, but it is relatively high in Asia, including Korea. Currently used as the standard primary treatment in metastatic or locally advanced BTC is gemcitabine/platinum combination chemotherapy.There is no standard secondary chemotherapy recognized after the failure of the gemcitabine/platinum first line treatment. The investigators try to evaluate role of 5-FU, leucovorin, irinotecan, and oxaliplatin combination chemotherapy (FOLFIRINOX) for the patients who progressed after gemcitabine/cisplatin first line chemotherapy.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: 5-Fluorouracil Drug: Leucovorin Drug: Irinotecan Drug: Oxaliplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: mFOLFIRINOX (5-FU, Irinotecan, oxaliplatin, Leucovorin)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Modified FOLFIRINOX in Patients With Metastatic Biliary Tract Cancer After Failure of Gemcitabine/Cisplatin Chemotherapy
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: mFOLFIRINOX
D1 Oxaliplatin 65 mg/m2 + 5% dextrose water (5DW) 200 mL mix IV over 2 hours followed by, D1 Leucovorin 400 mg/m2 + 5DW 200 ml mix IV over 2 hours D1 Irinotecan 135 mg/m2 + 5DW 500 mL mix IV over 2 hours (concurrent with the leucovorin infusion) D1-2 5-Fluorouracil 1000 mg/m2 + 5DW 1 liter (1L) continuous IV over 23 hours repeat every 2 weeks
Drug: 5-Fluorouracil
D1-2 5-Fluorouracil 1000 mg/m2 + 5DW 1L continuous IV over 23 hours q 2 weeks

Drug: Leucovorin
D1 Leucovorin 400 mg/m2 + 5DW 200 ml mix IV over 2 hours q 2 weeks

Drug: Irinotecan
D1 Irinotecan 135 mg/m2 + 5DW 500 mL mix IV over 2 hours (concurrent with the leucovorin infusion) q 2weeks

Drug: Oxaliplatin
D1 Oxaliplatin 65 mg/m2 + 5DW 200 mL mix IV over 2 hours q 2 weeks

Primary Outcome Measures :
  1. Response rate of treated participants [ Time Frame: up to 6 months ]
    Rate of response including complete response and partial response by treatment

Secondary Outcome Measures :
  1. Progression free survival (PFS) duration of treated participants [ Time Frame: up to 12 months ]
    duration measure from treatment day to progression + death events

  2. Overall survival (OS) duration of treated participants [ Time Frame: up to 12 months ]
    duration measure from treatment day to death events

  3. Incidence of Treatment-Emergent Adverse Events of participants [ Time Frame: up to 12 months ]
    all adverse events during treatment

  4. Evaluation of Life quality of participants [ Time Frame: up to 12 months ]
    Evaluate patients' life quality evaluation during treatment every 2 months with questionaires

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:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically confirmed BTC (cholangiocarcinoma or gall bladder (GB) cancer) , except ampulla of Vater cancer
  2. In the event that the progression of the gemcitabine/cisplatin is experienced during or after discontinuation of the first line treatment for metastatic, locally advanced or relapsed (it may be considered as a first line treatment that recurrence within six months of completion of the adjuvant or neo-adjuvant chemotherapy using gemcitabine/cisplatin)
  3. Patient (or legal representative) has completed an approved consent documents that he or she will participate in the test after receiving sufficient information about the clinical trial
  4. East clinical oncology group (ECOG) performance status 0-1
  5. One or more measurable lesions by RECIST v1.1.
  6. Appropriate organ functions; A. Liver: bilirubin ≤ 3 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 x ULN (in cases of liver metastasis, AST or ALT ≤ 5 x ULN) B. Kidney: An estimate of creatine clearance rate according to the Cockcroft-Gault formula (or local institution's standard method) > 30 mili-liter (mL)/min C. Hemoglobin ≥ 9 g/dL (transfusion allowed), absolute neutrophil count (ANC) ≥ 1500/μL, platelet count ≥ 75,000/μL.
  7. Expected life time over 3 months.
  8. Over 19 years old.
  9. In case of proper bile excretion function
  10. Have the will and ability to comply with the clinical trial plan during the study period, including treatment and scheduled visits and examination.
  11. For pre-menopausal women and for women less than one year after the onset of menopause, serum or urine pregnancy tests shall be confirmed negative during screening.
  12. For men and fertile women, the use of effective contraceptive methods should be agreed (effective contraception should be used for at least 30 days prior to the initial administration of a investigational drug, the trial period, and at least 90 days after the discontinuation of the test participation).

Exclusion Criteria:

  1. ≥ 2 of prior chemotherapy for progressive BTC (except for adjuvant/neo-adjuvant chemotherapy with resting of more than six months)
  2. Symptomatic or untreated brain metastasis or spinal cord compression metastasis.
  3. Previous treatment using Irinotecan or oxaliplatin
  4. In case of major surgery within four weeks just before registration, excluding biopsy for diagnosis
  5. In case of chemotherapy or radiation therapy was received within three weeks prior to the administration of a test medication
  6. Grade 2 or higher peripheral neuropathy
  7. Grade 2 or higher toxicities caused by a previous cancer treatment based on NCI-CTCAE v 4.03 other than hair loss
  8. A person diagnosed with another malignant tumor within the last five years. Exceptions include basal or squamous cell carcinoma of the skin or intraepithelial neoplasia (bladder, uterine cervical, colorectal, breast)
  9. Pregnant or nursing woman
  10. If there is a severe or uncontrolled systemic disease, active infection, active bleeding tendency or organ transplantation history (including allo-hematopoietic stem cell transplantation)
  11. The following virus infection A. Known positive history for human immunodeficiency virus (Human Immunodeficiency virus, HIV) test or known acquired immunodeficiency syndrome (AIDS) B. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (positive Hepatitis B surface -Ag (+) or HCV RNA (+) if anti-HCV Ab screening test is positive)
  12. If there is a known alcohol or drug abuse
  13. In cases of clinically significant (i.e., active) cardiovascular disease: cerebral hemorrhage/brain infarction, myocardial infarction (pre-registration < 6 months), unstable angina, congestive heart failure (NYHA classification ≥2) or arrhythmia needed drug therapy.
  14. In case of a mental state in which it is impossible to understand and provide the consent.

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): NCT03778593

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Contact: Sung Yong Oh, M.D. +82-51-240-5044

Sponsors and Collaborators
Dong-A University Hospital
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Principal Investigator: Sung Yong Oh, M.D. Dong-A University Hospital
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Responsible Party: Sung Yong Oh, Associate Professor, Dong-A University Hospital Identifier: NCT03778593    
Other Study ID Numbers: GF BTC-2018
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sung Yong Oh, Dong-A University Hospital:
biliary tract carcinoma
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Protective Agents
Vitamin B Complex
Growth Substances