Methods For Treating Pancreatic Cancer Using Combination Therapies Comprising Liposomal Irinotecan

A method of treating an exocrine pancreatic cancer, the method comprising intravenously administering to a patient having an exocrine pancreatic cancer 60-80 mg/m2 of irinotecan in an irinotecan liposome injection formulation in a total volume of 500 mL over about 90 minutes, in combination with 200 mg/m2 of the (1)-form of leucovorin or 400 mg/m2 of the (l+d) racemic form of leucovorin, and 1,800-2,400 mg/m2 5-fluorouracil to treat the exocrine pancreatic cancer in the human patient.

A method of treating an exocrine pancreatic cancer in a human patient who has previously been treated with gemcitabine, the method comprising intravenously administering to the patient 60-80 mg/m2 of irinotecan in an irinotecan liposome injection formulation in a total volume of 500 mL, in combination with 400 mg/m2 of the (l+d) racemic form of leucovorin and 2,400 mg/m2 5-fluorouracil to treat the exocrine pancreatic cancer in the patient, the irinotecan liposome injection formulation comprising irinotecan sucrose octasulfate encapsulated within a liposome comprising phosphatidylcholine, cholesterol, and a polyethyleneglycol-derivatized phosphatidyl-ethanolamine, and having a diameter of approximately 80-140 nm, wherein the irinotecan liposome, leucovorin and 5-fluorouracil are administered sequentially to the patient beginning on day 1 of a 2-week cycle.