Nal-IRI(Nanoliposomal Irinotecan) Plus 5-FU/LV in Metastatic Biliary Tract Cancer

NCT03524508 | Completed Phase 2

• 1 other identifier: NIFTY
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of combination of fluorouracil/folinic acid and liposomal irinotecan(Onivyde) compared with fluoruracil/folinic acid in patients with metastatic biliary tract cancer which progressed on 1st line gemcitabine/cisplatin.

Conditions

Metastatic Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival by independent central reviewer

  Progression-free survival is the time from the date of enrollment to the earlier of the date of confirmed progression or death from any cause.

  from the date of enrollment to the earlier of the date of confirmed progression or death from any cause. (assessed up to 36 months)

Secondary Outcomes (6)

• Overall Survival

  from the date of enrollment to death from any cause. (assessed up to 36 months)

• Response rates determined by the investigator according to the RECIST(Response Evaluation Criteria in Solid Tumors) v1.1

  from the date of enrollment to end of treatment. (assessed up to 36 months)

• EORTC-QLQ (European Organization for Research and Treatment of Cancer - Quality of life Questionnaire) C30 (version 3.0)

  from the date of Screening to end of treatment. (assessed up to 36 months)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  from the date of enrollment to 30 days after last treatment. (assessed up to 36 months)

• Progression Free Survival by investigator assessment

  from the date of enrollment to the earlier of the date of confirmed progression or death from any cause. (assessed up to 36 months)

Study Arms (2)

5-FU/LV/Onivyde

EXPERIMENTAL

Onivyde 70 mg/m2 (90 minutes), dl-LV 400mg/m2 or l-LV 200mg/m2 (30 minutes), 5-FU 2400 mg/m2 (46 hours) IV every 2 weeks.

Drug: Onivyde; Drug: 5-FU/LV

5FU/LV

ACTIVE COMPARATOR

dl-LV 400mg/m2 or l-LV 200mg/m2 (30 minutes), 5-FU 2400 mg/m2 (46 hours) IV every 2 weeks.

Drug: 5-FU/LV

Interventions

Onivyde DRUG

The recommended dose and regimen of Onivyde is 70 mg/m2 intravenously over 90 minutes, followed by dl-LV 400mg/m2 or l-LV 200mg/m2 intravenously over 30 minutes, followed by 5-FU 2400 mg/m2 intravenously over 46 hours, administered every 2 weeks.

Also known as: Liposomal irinotecan

5-FU/LV/Onivyde

5-FU/LV DRUG

The recommended dose and regimen of dl-LV 400mg/m2 or l-LV 200mg/m2 intravenously over 30 minutes, followed by 5-FU 2400 mg/m2 intravenously over 46 hours, administered every 2 weeks

Also known as: Fluorouracil/Folinic acid

5-FU/LV/Onivyde; 5FU/LV

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and written informed consent form
• ≥ 19 years of age
• Histologically or cytologically confirmed cholangiocarcinoma
• Documented metastatic disease
• At least one measurable lesion according to the RECIST v1.1
• Disease progression on gemcitabine-cisplatin combination therapy
• For patients whose disease recurred after curative resection (R0 or R1), previous adjuvant 5-FU-based chemotherapy is allowed if there is at least 6 month-interval between the last dose of adjuvant chemotherapy and recurrence of disease.
• Adequate hepatic, renal and hematological function AST(Aspartate Aminotransferase), ALT(Alanine Aminotransferase) ≤ 100 IU/L (100 U/L), Cr(Creatinine) ≤ 1.5mg/dL
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-1

You may not qualify if:

• Serum total bilirubin ≥2 x ULN(upper limit of normal) (biliary drainage is allowed for biliary obstruction)
• Severe renal impairment (Clcr ≤ 30 ml/min)
• Inadequate bone marrow reserves as evidenced by:
• ANC(Absolute Neutrophile Count) ≤ 1,500 cells/μl; or
• Platelet count ≤ 100,000 cells/μl; or
• Hemoglobin ≤ 9 g/dL
• ECOG performance status 2-4
• Any clinically significant disorder impacting the risk-benefit balance negatively per physician's judgment
• Any clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea \> grade 2
• Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months
• NYHA(New York Heart Association) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Or known abnormal ECG with clinically significant abnormal findings
• Active infection or an unexplained fever \>38.5°C (excluding tumor fever), which in the physician's opinion might compromise the patient's health
• Current use or any use in last two weeks of strong CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors
• Known hypersensitivity to any of the components of Onivyde other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, or leucovorin.
• Breast feeding, known pregnancy, positive serum pregnancy test or unwillingness to use an effective method of contraception, during therapy and for 3 months following the last dose of Onivyde. Females of Childbearing Potential must either agree to use and be able to take effective contraceptive birth control measures (Pearl Index \< 1) or agree to practice complete abstinence from heterosexual intercourse during the course of the study and for at least 3 months after last application of program treatment. A female subject is considered to be of childbearing potential unless she is age ≥ 50 years and naturally amenorrhoeic for ≥ 2 years, or unless she is surgically sterile. Males must agree not to father a child (including not donating sperm) during the course of the trial and for at least 6 months after last administration of study drugs.

Sponsors & Collaborators

• Changhoon Yoo: lead
• Ulsan University Hospital: collaborator
• Chungnam National University Hospital: collaborator
• Kyungpook National University Chilgok Hospital: collaborator
• Inje University: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (25)

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Related Links

• Camptosar® (irinotecan) U.S. Package Insert (Accessed 23 March 2016)
• Irinotecan hydrochloride Summary of Product Characteristics (Accessed 23 March 2016)

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

irinotecan sucrosofate; Fluorouracil; Leucovorin

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

Study Officials

• Changhoon Yoo

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 14, 2018
• Study Start: September 4, 2018
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2021
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)