Trial of Infusional FOLFIRINOX in First Line Treatment of Advanced Bil

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

Currently recruiting.

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https://clinicaltrials.gov/ct2/show/NCT03291899

Purpose
This study is to Evaluate the response rate and toxicity profile of infusional 5 fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFIRINOX) in 1st 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 Intervention Phase
Biliary Tract Cancer
Combination Product: FOLFIRINOX
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Drug Information available for: Fluorouracil Oxaliplatin Irinotecan
Genetic and Rare Diseases Information Center resources: Biliary Tract Cancer
U.S. FDA Resources

Further study details as provided by Shouki Bazarbashi, King Faisal Specialist Hospital & Research Center:

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

Secondary Outcome Measures:
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

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

Estimated Enrollment: 32
Actual Study Start Date: January 3, 2017
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental single arm
Chemotherapy using the FOLFIRINOX regimen will be given every 2 weeks for a total of 12 cycles. FOLFIRINOX consist of:
Oxaliplatin-85 mg/m2 IV Day 1
Leucovorin-400 mg/m2 IV Day 1
Irinotecan-180 mg/m2 IV Day 1
Fluorouracil (FU)-400 mg/m2 IV bolus Day 1
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

Show Detailed Description

Eligibility
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.

Ages Eligible for Study: 19 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:
Histologically confirmed locally advanced (irresectable) or metastatic biliary tract cancers.
Measurable disease. Defined as tumor that have uni or bi dimensional measurement not less than 1.5 cm on any dimension.
Age ≥ 18 years.
Signed written informed consent before enrolment.
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.
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.
Life expectancy of 6 months or more.
Eastern Cooperative Oncology Group performance status of 0-1.
Adequate renal function: creatinine within normal institutional range.
Adequate hepatic function: Total bilirubin within normal institutional limits, serum AST and ALT 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.
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:
Known or suspected dihydropyrimidine deficiency.
Presence of CNS metastasis.
Previous malignancy within 5 years, except adequately treated non melanomatous skin cancer or in situ cervical cancer.
Severe cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, myocardial infarction or significant arrhythmias).
Psychiatric or mental disorder, precluding understanding of the information of the trial related topics and giving valid informed consent.
Active uncontrolled infection.
Pregnant patients (confirmed by β-HCG test where appropriate).
Serious underlying medical condition (in the judgement of the investigator) which could impair the ability of the patient to participate in the trial.
Any psychological, familial, geographic or social circumstances which could impair the patient’s ability to participate in the trial and comply with follow up.
Treatment with other experimental drugs within 30 days of entry into the trial.
Treatment with other anti-cancer therapy.
Known hypersensitivity to any of the study drugs.
Breast feeding
Legal incapacity.
Patients with a known diagnosis of HIV infection.
Contacts and Locations
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
More Information

Publications:
Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.

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 Submitted: September 21, 2017
First Posted: September 25, 2017
Last Update Posted: September 25, 2017
Last Verified: September 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