FOLFIRINOX for 2nd-line Treatment of BTC

NCT03778593 | Completed Phase 2 DMC

• 1 other identifier: GF BTC-2018
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Cancer

Keywords

biliary tract carcinoma; 5-FU; Irinotecan; oxaliplatin

Outcome Measures

Primary Outcomes (1)

• Response rate of treated participants

  Rate of response including complete response and partial response by treatment. Response will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  up to 6 months

Secondary Outcomes (3)

• Progression free survival (PFS) duration of treated participants

  up to 12 months

• Overall survival (OS) duration of treated participants

  up to 12 months

• Incidence of Treatment-Emergent Adverse Events of participants

  up to 12 months

Other Outcomes (1)

• EORTC -QoL-C30

  up to 12 months

Study Arms (1)

mFOLFIRINOX

EXPERIMENTAL

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; Drug: Leucovorin; Drug: Irinotecan; Drug: Oxaliplatin; Drug: 5% dextrose water

Interventions

5-Fluorouracil DRUG

D1-2 5-Fluorouracil 1000 mg/m2 + 5DW 1L continuous IV over 23 hours q 2 weeks

mFOLFIRINOX

Leucovorin DRUG

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

mFOLFIRINOX

Irinotecan DRUG

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

mFOLFIRINOX

Oxaliplatin DRUG

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

mFOLFIRINOX

5% dextrose water DRUG

mix fluid with 5-FU, leucovorin, irinotecan, and oxaliplatin

Also known as: 5DW

mFOLFIRINOX

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed BTC (cholangiocarcinoma or gall bladder (GB) cancer) , except ampulla of Vater cancer
• 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)
• 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
• East clinical oncology group (ECOG) performance status 0-1
• One or more measurable lesions by RECIST v1.1.
• 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.
• Expected life time over 3 months.
• Over 19 years old.
• In case of proper bile excretion function
• Have the will and ability to comply with the clinical trial plan during the study period, including treatment and scheduled visits and examination.
• 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.
• 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).

You may not qualify if:

• ≥ 2 of prior chemotherapy for progressive BTC (except for adjuvant/neo-adjuvant chemotherapy with resting of more than six months)
• Symptomatic or untreated brain metastasis or spinal cord compression metastasis.
• Previous treatment using Irinotecan or oxaliplatin
• In case of major surgery within four weeks just before registration, excluding biopsy for diagnosis
• In case of chemotherapy or radiation therapy was received within three weeks prior to the administration of a test medication
• Grade 2 or higher peripheral neuropathy
• Grade 2 or higher toxicities caused by a previous cancer treatment based on NCI-CTCAE v 4.03 other than hair loss
• 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)
• Pregnant or nursing woman
• If there is a severe or uncontrolled systemic disease, active infection, active bleeding tendency or organ transplantation history (including allo-hematopoietic stem cell transplantation)
• 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)
• If there is a known alcohol or drug abuse
• 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.
• In case of a mental state in which it is impossible to understand and provide the consent.

Sponsors & Collaborators

• Dong-A University Hospital: lead

Study Sites (1)

Dong-A University Hospital

Busan, 49201, South Korea

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Fluorouracil; Leucovorin; Irinotecan; Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids; Coordination Complexes; Organic Chemicals

Study Officials

• Sung Yong Oh, M.D.

  Dong-A University Hospital

  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: Associate Professor

Model Details: mFOLFIRINOX (5-FU, Irinotecan, oxaliplatin, Leucovorin)

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 19, 2018
• Study Start: March 1, 2019
• Primary Completion: March 1, 2019
• Study Completion: January 14, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)