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.

1 - 20 . (canceled) 
     
     
         21 . A method of treating metastatic adenocarcinoma of the pancreas in a human patient who has previously been treated with the antineoplastic agent gemcitabine, the method comprising:
 intravenously administering to the patient once every two weeks   irinotecan sucrose octasulfate salt liposome injection in a dose providing the equivalent of 70 mg/m 2  of irinotecan free base,   in combination with   2400 mg/m 2  of the antineoplastic agent 5-fluorouracil.   
     
     
         22 . The method of  claim 21 , wherein the metastatic adenocarcinoma of the pancreas has progressed on gemcitabine based therapy prior to the administration of the irinotecan sucrose octasulfate liposome injection. 
     
     
         23 . The method of  claim 21 , wherein the irinotecan sucrose octasulfate salt liposome injection is administered intravenously over 90 minutes. 
     
     
         24 . The method of  claim 21 , wherein the 5-fluorouracil is administered intravenously over 46 hours. 
     
     
         25 . The method of  claim 21 , wherein the irinotecan sucrose octasulfate salt liposome injection comprises phosphatidylcholine, cholesterol, and a polyethyleneglycol-derivatized phosphatidyl-ethanolamine. 
     
     
         26 . The method of  claim 25 , wherein the polyethylene glycol in the polyethyleneglycol-derivatized phosphatidyl-ethanolamine is N-(methoxy-poly(ethyleneglycol) (M.W. 2000)-oxycarbonyl)-distearoylphosphatidylethanolamine. 
     
     
         27 . The method of  claim 25 , wherein the polyethyleneglycol-derivatized phosphatidyl-ethanolamine is in the amount of approximately one polyethyleneglycol derivatized phosphatidyl-ethanolamine molecule for 200 phospholipid molecules. 
     
     
         28 . The method of  claim 27 , wherein the sucrose octasulfate salt liposome injection comprises phosphatidylcholine, cholesterol, and N-(methoxy-poly(ethyleneglycol) (M.W. 2000)-oxycarbonyl)-distearoylphosphatidylethanolamine in a molar ratio of 3:2:0.015. 
     
     
         29 . The method of  claim 28 , wherein the irinotecan sucrose octasulfate salt liposome injection is administered intravenously over 90 minutes and the 5-fluorouracil is administered intravenously over 46 hours. 
     
     
         30 . The method of  claim 21 , wherein, beginning on day 1 of a 2-week cycle, the 5-fluorouracil is administered to the patient after administration of irinotecan sucrose octasulfate salt liposome injection. 
     
     
         31 . The method of  claim 21 , further comprising premedicating the patient with an anti-emetic prior to administering the antineoplastic therapy. 
     
     
         32 . The method of  claim 23 , further comprising premedicating the patient with an anti-emetic prior to administering the antineoplastic therapy. 
     
     
         33 . The method of  claim 24 , further comprising premedicating the patient with an anti-emetic prior to administering the antineoplastic therapy.