Nal-IRI plus 5-FU/LV and Nab-Paclitaxel plus Gemcitabine alternately every two months
Nal-IRI at 80 mg/m2 IV over 90 minutes followed by folinic acid (leucovorin 400 mg/m2 IV, or Elvorin 200 mg/m2 IV over 30 minutes) then by 5-FU 2400 mg/m2 IV over 46-hours, every 2 weeks.
Nab-Paclitaxel + Gemcitabine (6 injections, one injection three weeks out of four; so ≈ 2 months per cycle)
Day 1 (D1): Nab-Paclitaxel plus Gemcitabine at the dose of :
Gemcitabine: 1000 mg/m² in 500 ml normal saline infusion at a fixed dose rate of 10 mg/m²/min (i.e. 100 min).
Nab-Paclitaxel: 125 mg/m2 This treatment is administered at D1, D8, D15 and at D29, D36, D43.

Nal-IRI plus 5-FU/LV Nal-IRI at 80 mg/m2 IV over 90 minutes followed by folinic acid (leucovorin 400 mg/m2 IV, or Elvorin 200 mg/m2 IV over 30 minutes) then by 5-FU 2400 mg/m2 IV over 46-hours, every 2 weeks.

Nab-Paclitaxel plus Gemcitabine Nab-Paclitaxel + Gemcitabine (6 courses, one course three weeks out of four; so ≈ 2 months per cycle)
Day 1 (D1): Nab-Paclitaxel + Gemcitabine at the dose of :
Gemcitabine: 1000 mg/m² in 500 ml normal saline infusion at a fixed dose rate of 10 mg/m²/min (i.e. 100 min).
Nab-Paclitaxel: 125 mg/m2 This treatment is administered at D1, D8, D15 and at D29, D36, D43.

Metastatic Pancreatic Cancer

Irinotecan Liposomal Injection

5-FU 2400 mg/m2 IV over 46-hours, every 2 weeks.

5-FU/LV

Nab-Paclitaxel: 125 mg/m2 This treatment is administered at D1, D8, D15 and at D29, D36, D43.

Nab-Paclitaxel

1000 mg/m² in 500 ml normal saline infusion at a fixed dose rate of 10 mg/m²/min (i.e. 100 min). This treatment is administered at D1, D8, D15 and at D29, D36, D43.

Gemcitabine

Clinique privée de l'Europe

CHU Hôtel Dieu

Hôpital privé

CH de la Côte Basque

CHU Avicenne

CH Duchenne

Hôpital Privé Sainte Marie

CHU Estaing

Hopitaux civils de Colmar

CH Sud Francilien

Centre GF Leclerc

Institut de cancérologie de Bourgogne

Hôpital Emile Roux

CH Docteur Schaffner

CHU Dupuytren

Clinique privée Jean Mermoz

Hôpital Européen

Institut Paoli Calmettes

Centre médical Oncogard

CH Privé Sainte Marie

Groupe Hospitalier La Pitié Salpêtrière

Hôpital Cochin

Hôpital Tenon

Hopital Européen Georges Pompidou

CH Saint Jean

Centre Cario HPCA

CH Jacques Puel

CHU Charles Nicolle

CH Foch

CHRU de Nancy

CHU Clarac

First Line Metastatic Pancreatic Cancer : 5FU/LV+Nal-IRI, Gemcitabine+Nab-paclitaxel or a Sequential Regimen of 2 Months 5FU/LV+Nal-IRI

Randomized Phase II Study Comparing 5FU/LV+Nal-IRI, Gemcitabine+Nab-paclitaxel or a Sequential Regimen of 2 Months 5FU/LV+Nal-IRI Followed by Two Months of Gemcitabine+Nab-paclitaxel, in Metastatic Pancreatic Cancer

PFS is defined as the time between the date of randomization and the date of the first radiological and/or clinical progression or the date of death (for whatever reason). Patients living without progression will be censured at date of last news. Progression is assessed by investigator and central review according to RECIST v1.1 criteria.

BOR is defined as complete or partial response rate according to scans and RECIST v1.1 criteria over the entire treatment period.

OS is defined as the time between the date of randomization and the date of death (whatever the cause). Alive patients will be censured at date of last news.

Time to treatment failure is defined as the time between the date of randomization and the date of discontinuation of all protocol treatments (regardless of cause) or date last news for patients alive under treatment.

Toxicities are evaluated according to NCI-CTC v4.0.

Federation Francophone de Cancerologie Digestive

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

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

Metastatic Biliary Tract Cancer

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

Onivyde

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

Camptosar® (irinotecan) U.S. Package Insert (Accessed 23 March 2016)

Irinotecan hydrochloride Summary of Product Characteristics (Accessed 23 March 2016)

Asan Medical Center

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

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

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.

Overall survival is the time from the date of enrollment to death from any cause

The response rate is the proportion of eligible patients with measurable lesions with a overall response of CR(Complete Response) or PR(Partial Response)

EORTC-QLQ C-30 questionnaires will be performed at screening visit, at pre-dose (Cycle 1 Day1) of every subsequent cycle, at the end of treatment visit. It is a 30‐item questionnaire. It has 4-point scales for the item number 1 to 28. These are coded with the same response categories as items 1 to 28, namely "not at all=1" "a little=2" "quite a bit=3" and "very much=4" It has 7-point scale for question number 29 to 30. These are coded with the same response categories as items 29 to 30, namely "worst=1" to "best=7" Total score will be minimum 30 and maximum 126.

Severity of adverse events will be graded by NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events) v4.03

Changhoon Yoo

Assistant Professor

Ulsan University Hospital

Chungnam National University Hospital

Kyungpook National University Chilgok Hospital

Inje University

interleukin-1-alpha antagonist (Xilonix) in addition to standard chemotherapy of onivyde and 5-fluorouracil/folinic acid (leucovorin)

Pancreatic Cancer

Cachexia

Weight Loss

Xilonix plus Onivyde and 5FU

Cedars-Sinai Medical Center

Study of Onivyde and 5-FU in Combination With Xilonix for Pancreatic Cancer With Cachexia

A Phase I Study of Onivyde and 5-FU in Combination With Xilonix for Advanced Pancreatic Cancer With Cachexia

Assess MTD of Onivyde in combination with novel therapy

Mean change from baseline (kg) up to 6 months

To measure overall survival up to 12 months from baseline

To measure progression free survival up to 12 months from baseline

Assessment based on patient-reported QOL up to 6 months from baseline

Assessment based on patient-reported outcomes up to 6 months from baseline

folinic acid/atrofija

First Line Metastatic Pancreatic Cancer : 5FU/LV+Nal-IRI, Gemcitabine+Nab-paclitaxel or a Sequential Regimen of 2 Months 5FU/LV+Nal-IRI

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

Study of Onivyde and 5-FU in Combination With Xilonix for Pancreatic Cancer With Cachexia

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