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Trial of Infusional FOLFIRINOX in First Line Treatment of Advanced Biliary Tract Cancers (FBI-TRAC)

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ClinicalTrials.gov Identifier: NCT03291899
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Shouki Bazarbashi, King Faisal Specialist Hospital & Research Center

Brief Summary:
This study is to evaluate the response rate and toxicity profile of infusional 5 fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFIRINOX) in first-line treatment of advanced biliary tract cancers and also to assess progression free survival and overall survival of FOLFIRINOX in first line treatment of advanced biliary tract cancers

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Combination Product: FOLFIRINOX Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Simon 2-stage optimum design Model
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Infusional 5 FLUOROURACIL, LEUCOVORIN, OXALIPLATIN AND IRINOTECAN (FOLFIRINOX) in First Line Treatment of Advanced Biliary Tract Cancers
Actual Study Start Date : January 3, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental single arm

Chemotherapy using the FOLFIRINOX regimen will be given every 2 weeks for a total of 12 cycles. FOLFIRINOX consist of:

  1. Oxaliplatin-85 mg/m2 IV Day 1
  2. Leucovorin-400 mg/m2 IV Day 1
  3. Irinotecan-180 mg/m2 IV Day 1
  4. Fluorouracil (FU)-400 mg/m2 IV bolus Day 1
  5. Fluorouracil 2400 mg/m2 infused over 46 hours starting day 1
Combination Product: FOLFIRINOX
combination chemotherapy using Oxaliplatin, Irinotecan, Leucovorin and Fluorouracil, given every 15 days for a total of 12 cycles




Primary Outcome Measures :
  1. Response rate [ Time Frame: 3 year ]
    Evaluate the response rate using RECIST 1.1 criteria


Secondary Outcome Measures :
  1. progression free survival [ Time Frame: 4 years ]
    calculated from day 1 of chemotherapy till either progression, death or date of last follow up whichever comes first

  2. overall survival [ Time Frame: 4 years ]
    calculated from day 1 of chemotherapy till either death or date of last follow up whichever comes first



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Histologically confirmed locally advanced (irresectable) or metastatic biliary tract cancers.
  2. Measurable disease. Defined as tumor that have uni or bi dimensional measurement not less than 1.5 cm on any dimension.
  3. Age ≥ 18 years.
  4. Signed written informed consent before enrolment.
  5. No prior chemotherapy or anti-neoplastic therapy other than radiotherapy more than 4 weeks prior to enrolment and to areas other than the measurable disease.
  6. Patients of either sex or child bearing age must be willing to use adequate contraceptive measures during the study and for 6 months after treatment.
  7. Life expectancy of 6 months or more.
  8. Eastern Cooperative Oncology Group performance status of 0-1.
  9. Adequate renal function: creatinine within normal institutional range.
  10. Adequate hepatic function: Total bilirubin within normal institutional limits, serum aspartate aminotransferase and alanine aminotransferase levels ≤2.5 times the institutional upper limit of normal or ≤ 5 times the institutional upper limit of normal of elevated because of liver involvement.
  11. Adequate hematological values: leukocyte count ≥3.0 x 109/L, an absolute neutrophil count ≥1.5 x 109/L, a platelet count ≥100 x 109/L.

Exclusion Criteria:

  1. Known or suspected dihydropyrimidine deficiency.
  2. Presence of central nervous system metastasis.
  3. Previous malignancy within 5 years, except adequately treated non melanomatous skin cancer or in situ cervical cancer.
  4. Severe cardiovascular disease (congestive heart failure New York Heart Association class three or four, unstable angina pectoris, myocardial infarction or significant arrhythmias).
  5. Psychiatric or mental disorder, precluding understanding of the information of the trial related topics and giving valid informed consent.
  6. Active uncontrolled infection.
  7. Pregnant patients (confirmed by β-Human chorionic gonadotrophin test where appropriate).
  8. Serious underlying medical condition (in the judgement of the investigator) which could impair the ability of the patient to participate in the trial.
  9. Any psychological, familial, geographic or social circumstances which could impair the patient's ability to participate in the trial and comply with follow up.
  10. Treatment with other experimental drugs within 30 days of entry into the trial.
  11. Treatment with other anti-cancer therapy.
  12. Known hypersensitivity to any of the study drugs.
  13. Breast feeding
  14. Legal incapacity.
  15. Patients with a known diagnosis of HIV infection.

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 ClinicalTrials.gov identifier (NCT number): NCT03291899


Contacts
Contact: Shouki H Bazarbashi, MD 966505443546 bazarbashi@gmail.com

Locations
Saudi Arabia
king Faisal Specialist Hospital and Research Center Recruiting
Riyadh, Saudi Arabia, 11211
Contact: Shouki Bazarbashi, MBBS    966505443546    bazarbashi@gmail.com   
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Shouki Bazarbashi King Faisal Specialist Hospital and Research cente

Publications of Results:
Responsible Party: Shouki Bazarbashi, section Head,Medical oncology, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT03291899     History of Changes
Other Study ID Numbers: RAC 2161 099
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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