Methods for Treating Metastatic Pancreatic Cancer Using Combination Therapies Comprising Liposomal Irinotecan and Oxaliplatin

Patent metadata

Field	Value
Publication number	US-2023062425-A1
Application number	US-202217711500-A
Country	US
Kind code	A1
Filing date	Apr 1, 2022
Priority date	Aug 21, 2015
Publication date	Mar 2, 2023
Grant date	—

Abstract

Combination therapy regimens including liposomal irinotecan, oxaliplatin and 5-fluorouracil are useful in the treatment of pancreatic cancer, including treatment of patients diagnosed with previously untreated metastatic adenocarcinoma of the pancreas. The combination therapy can include the administration of liposomal irinotecan, oxaliplatin, leucovorin and 5-fluorouracil once every two weeks.

First claim

1 .- 20 . (canceled)

21 . A method of treating metastatic adenocarcinoma of the pancreas in a human patient who has not previously received gemcitabine to treat the metastatic adenocarcinoma of the pancreas, the method comprising administering an antineoplastic therapy to the patient once every two weeks, the antineoplastic therapy consisting of:
a. 60 mg/m 2 of liposomal irinotecan, b. 60 mg/m 2 oxaliplatin, c. 200 mg/m 2 of the (l)-form of leucovorin or 400 mg/m 2 of the (l+d) racemic form of leucovorin, and d. 2,400 mg/m 2 5-fluorouracil; to treat the metastatic adenocarcinoma of the pancreas in the human patient, wherein the liposomal irinotecan comprises irinotecan sucrose octasulfate encapsulated in liposomes comprising 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), cholesterol, and a N-(carbonylmethoxypolyethlyene glycol-2000)-1,2-distearoly-sn-glycero-3-phosphoethanolamine (MPEG-2000-DSPE).

22 . The method of claim 21 , wherein each administration of the oxaliplatin begins 2 hours after completing each administration of the liposomal irinotecan.

23 . The method of claim 21 , wherein the 5-fluorouracil is administered as an infusion over 46 hours.

24 . The method of claim 21 , wherein the leucovorin is administered immediately prior to the 5-fluorouracil.

25 . The method of claim 21 , wherein the liposomal irinotecan, oxaliplatin and leucovorin are administered on days 1 and 15 of a 28-day treatment cycle.

26 . The method of claim 21 , wherein the liposomal irinotecan is administered as an infusion over about 90 minutes.

27 . The method of claim 21 , wherein the liposomal irinotecan is administered, followed by administering the oxaliplatin, followed by administering the leucovorin, followed by administering the 5-fluorouracil.

28 . The method of claim 21 , wherein the liposomal irinotecan, oxaliplatin, leucovorin, and 5-fluorouracil are administered beginning on days 1 and 15 of a 28-day treatment cycle; each administration of the liposomal irinotecan is administered prior to each administration of the leucovorin; each administration of the leucovorin is administered immediately prior to each administration of the 5-fluorouracil; and each administration of the 5-fluorouracil is administered as an infusion over 46 hours.

29 . The method of claim 21 , wherein each administration of the oxaliplatin begins after completing each administration of the liposomal irinotecan, and the method further comprises administering a corticosteroid and an anti-emetic to the patient prior to the antineoplastic therapy.

Assignees

• Ipsen Biopharm Ltd

Inventors

• Bayever Eliel
• Blanchette Sarah F
• Fitzgerald Jonathan Basil
• Gaddy Daniel F
• Hendriks Bart S
• Kalra Ashish
• Lee Helen

Classifications

• A61K31/4745 Primary

  condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines (yohimbine derivatives, vinblastine A61K31/475; ergoline derivatives A61K31/48) · CPC title

• A61K31/282 Primary

  Platinum compounds · CPC title

• A61K2300/00

  Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00 · CPC title

• A61K9/127

  Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant · CPC title

• A61K31/513

  having oxo groups directly attached to the heterocyclic ring, e.g. cytosine · CPC title