Trial of Infusional FOLFIRINOX in First Line Treatment of Advanced Biliary Tract Cancers

NCT03291899 | Terminated Phase 2

• 1 other identifier: RAC 2161 099
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Response rate

  Evaluate the response rate using RECIST 1.1 criteria

  3 year

Secondary Outcomes (2)

• progression free survival

  4 years

• overall survival

  4 years

Study Arms (1)

Experimental single arm

EXPERIMENTAL

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

Interventions

FOLFIRINOX COMBINATION_PRODUCT

combination chemotherapy using Oxaliplatin, Irinotecan, Leucovorin and Fluorouracil, given every 15 days for a total of 12 cycles

Experimental single arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.
• 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.

You may not qualify if:

• Known or suspected dihydropyrimidine deficiency.
• Presence of central nervous system metastasis.
• Previous malignancy within 5 years, except adequately treated non melanomatous skin cancer or in situ cervical cancer.
• Severe cardiovascular disease (congestive heart failure New York Heart Association class three or four, 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-Human chorionic gonadotrophin 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.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

king Faisal Specialist Hospital and Research Center

Riyadh, 11211, Saudi Arabia

Location

Related Publications (2)

• Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge 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.

  PMID: 21561347 RESULT

• 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.

  PMID: 20375404 RESULT

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

folfirinox

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Shouki Bazarbashi

  King Faisal Specialist Hospital and Research cente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: section Head,Medical oncology

Model Details: Simon 2-stage optimum design Model

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 25, 2017
• Study Start: January 3, 2017
• Primary Completion: February 9, 2023
• Study Completion: February 9, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)