Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan

Abstract

Provided are methods for treating pancreatic cancer in a patient by administering liposomal irinotecan (MM-398) alone or in combination with additional therapeutic agents. In one embodiment, the liposomal irinotecan (MM-398) is co-administered with 5-fluorouracil and leucovorin.

What is claimed is: 
     
         1 . A method of treating a solid tumor in a patient, the method comprising administering to the patient in need thereof a single dose of 60, 70, 80, 120 or 180 mg/m 2  MM-398 liposomal irinotecan once every two weeks in an intravenous pharmaceutical formulation. 
     
     
         2 . The method of  claim 1 , wherein at least a portion of the irinotecan in the MM-398 liposomal irinotecan administered to the patient is converted to the metabolite SN-38 and the total AUC of SN-38 in the plasma increases less than proportionally with the dose of total irinotecan administered to the patient in the MM-398 liposomal irinotecan. 
     
     
         3 . The method of  claim 1 , wherein the total AUC of irinotecan in the plasma increases less than proportionally with the dose of total irinotecan administered to the patient in the MM-398 liposomal irinotecan. 
     
     
         4 . The method of  claim 1 , wherein the liposomal irinotecan is administered to patients not homozygous for the UGT1A1*28 allele at a dose of 80 mg/m 2  MM-398 liposomal irinotecan. 
     
     
         5 . The method of  claim 1 , wherein the liposomal irinotecan is administered to patients homozygous for the UGT1A1*28 allele at a dose of 60 mg/m 2  MM-398 liposomal irinotecan. 
     
     
         6 . The method of  claim 1 , wherein the MM-398 liposomal irinotecan is administered as an intravenous infusion over 90 minutes. 
     
     
         7 . A method of treating a solid tumor in a patient, the method comprising administering to the patient not homozygous for the UGT1A1*28 allele in need thereof a single dose of 60, 70, 80 or 120 mg/m 2  MM-398 liposomal irinotecan once every two weeks in an intravenous pharmaceutical formulation. 
     
     
         8 . The method of  claim 7 , wherein at least a portion of the irinotecan in the MM-398 liposomal irinotecan administered to the patient is converted to the metabolite SN-38 and the total AUC of SN-38 in the plasma increases less than proportionally with the dose of total irinotecan administered to the patient in the MM-398 liposomal irinotecan. 
     
     
         9 . The method of  claim 8 , wherein the MM-398 liposomal irinotecan is administered as an intravenous infusion over 90 minutes. 
     
     
         10 . A method of treating a solid tumor in a patient, the method comprising administering to the patient not homozygous for the UGT1A1*28 allele in need thereof a single dose of 80 mg/m 2  MM-398 liposomal irinotecan once every two weeks in an intravenous pharmaceutical formulation.