Nal-IRI(Nanoliposomal Irinotecan) Plus 5-FU/LV in Metastatic Biliary Tract Cancer
NCT ID: NCT03524508
Last Updated: 2022-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
178 participants
INTERVENTIONAL
2018-09-04
2021-12-31
Brief Summary
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Detailed Description
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Eligible patients will be included in this study and treated according to the protocol. Study treatment will be continued until disease progression, unacceptable toxicity, or patient's decision/consent withdrawal. Local investigators will determine disease progression, radiologic or clinical deterioration.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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5-FU/LV/Onivyde
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.
Onivyde
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.
5-FU/LV
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
5FU/LV
dl-LV 400mg/m2 or l-LV 200mg/m2 (30 minutes), 5-FU 2400 mg/m2 (46 hours) IV every 2 weeks.
5-FU/LV
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
Interventions
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Onivyde
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.
5-FU/LV
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ≥ 19 years of age
3. Histologically or cytologically confirmed cholangiocarcinoma
4. Documented metastatic disease
5. At least one measurable lesion according to the RECIST v1.1
6. Disease progression on gemcitabine-cisplatin combination therapy
7. 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.
8. Adequate hepatic, renal and hematological function AST(Aspartate Aminotransferase), ALT(Alanine Aminotransferase) ≤ 100 IU/L (100 U/L), Cr(Creatinine) ≤ 1.5mg/dL
9. Eastern Cooperative Oncology Group (ECOG) Performance status 0-1
Exclusion Criteria
2. Severe renal impairment (Clcr ≤ 30 ml/min)
3. 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
4. ECOG performance status 2-4
5. Any clinically significant disorder impacting the risk-benefit balance negatively per physician's judgment
6. Any clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea \> grade 2
7. Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months
8. 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
9. Active infection or an unexplained fever \>38.5°C (excluding tumor fever), which in the physician's opinion might compromise the patient's health
10. Current use or any use in last two weeks of strong CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors
11. Known hypersensitivity to any of the components of Onivyde other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, or leucovorin.
12. 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.
13. Previous treatment with combination drug tegafur, gimeracil, and oteracil potassium with seven days before enrollment.
14. Current treatment with Sorivudine.
15. Severe fatigue or bone marrow depression after prior radiotherapy or antineoplastic therapy
16. Pregnancy or women with child-bearing potential or lactating
17. Non-malignant severe co-morbidity
18. Previous second-line anti-cancer therapy (e.g., Tegafur)
19. History of other malignancy with a disease-free interval \<5 years (Registration is permitted if it has minimal impact on prognosis, such as carcinoma in situ and papillary thyroid cancer)
20. History or current eveidence of brain metastasis
19 Years
ALL
No
Sponsors
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Ulsan University Hospital
OTHER
Chungnam National University Hospital
OTHER
Kyungpook National University Chilgok Hospital
OTHER
Inje University
OTHER
Changhoon Yoo
OTHER
Responsible Party
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Changhoon Yoo
Assistant Professor
Principal Investigators
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Changhoon Yoo
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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References
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Related Links
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Camptosar® (irinotecan) U.S. Package Insert (Accessed 23 March 2016)
Irinotecan hydrochloride Summary of Product Characteristics (Accessed 23 March 2016)
Other Identifiers
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NIFTY
Identifier Type: -
Identifier Source: org_study_id
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