Methods for Treating Pancreatic Cancer Using Combination Therapies

A method of treating patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy who are not homozygous for the UTG1A1*28 allele, the method comprising intravenously administering to the patient in need thereof an antineoplastic therapy once every two weeks, the antineoplastic therapy consisting of:

• a. administering liposomal irinotecan as an intravenous infusion over 90 minutes in an amount providing 70 mg/m2 of irinotecan free base, the liposomal irinotecan composition comprising irinotecan encapsulated in irinotecan liposomes having an area under the plasma concentration curve extrapolated to time infinity (AUC0-∞) of about 1091-1705 [h·μg/mL];
• followed by
• b. 200 mg/m2 of the (l) form of leucovorin;
• and
• c. 2,400 mg/m2 of 5-fluorouracil.

A method of treating pancreatic cancer in a human patient who has previously been treated with gemcitabine, the method comprising intravenously administering to the patient in need thereof an antineoplastic therapy once every two weeks, the antineoplastic therapy consisting of:

• a single dose of 70 mg/m2 of irinotecan free base in an irinotecan nanoparticle composition comprising irinotecan nanoparticles having a diameter of 80-140 nm, administered in combination with 200 mg/m2 of the (l) form of leucovorin and 2,400 mg/m2 of 5-fluorouracil, to treat the pancreatic cancer in the human patient, wherein the irinotecan nanoparticle composition has one or more characteristics selected from the group consisting of:
• a. an area under the plasma concentration curve extrapolated to time infinity (AUC0-∞) of about 1091-1705 [h·μg/mL];
• and
• b. a maximum plasma concentration of about 29-47 micrograms/mL.