Randomized Phase II Trial of Fluorouracil and Folinic Acid With or Without Liposomal Irinotecan (ONIVYDE) for Patients With Metastatic Biliary Tract Cancer Which Progressed Following Gemcitabine Plus Cisplatin
Overview
- Phase
- Phase 2
- Intervention
- 5-FU/LV
- Conditions
- Metastatic Biliary Tract Cancer
- Sponsor
- Changhoon Yoo
- Enrollment
- 178
- Locations
- 1
- Primary Endpoint
- Progression Free Survival by independent central reviewer
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Detailed Description
This study is a multicenter, open-label, randomized, phase II study comparing the efficacy and safety between fluorouracil/folinic acid plus liposomal irinotecan and fluoruracil/folinic acid monotherapy in patients with metastatic biliary tract cancer which progressed on 1st line gemcitabine/cisplatin. 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.
Investigators
Changhoon Yoo
Assistant Professor
Asan Medical Center
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
5FU/LV
dl-LV 400mg/m2 or l-LV 200mg/m2 (30 minutes), 5-FU 2400 mg/m2 (46 hours) IV every 2 weeks.
Intervention: 5-FU/LV
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.
Intervention: Onivyde
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.
Intervention: 5-FU/LV
Outcomes
Primary Outcomes
Progression Free Survival by independent central reviewer
Time Frame: from the date of enrollment to the earlier of the date of confirmed progression or death from any cause. (assessed up to 36 months)
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.
Secondary Outcomes
- 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))
- Response rates determined by the independent central reviewer(from the date of enrollment to end of treatment. (assessed up to 36 months))