Local Drug Delivery Devices and Methods for Treating Cancer

Abstract

Drug-eluting devices and methods for the treatment of tumors of the pancreas, biliary system, gallbladder, liver, small bowel, or colon, are provided. Methods include deploying a drug-eluting device having a film which includes a mixture of a degradable polymer and a chemotherapeutic drug, wherein the film has a thickness from about 2 μm to about 1000 μm, into a tissue site and releasing a therapeutically effective amount of the chemotherapeutic drug from the film to treat the tumor, wherein the release of the therapeutically effective amount of the drug from the film is controlled by in vivo degradation of the polymer at the tissue site.

1 . A drug-eluting device for the treatment of a tumor of the pancreas, biliary system, gallbladder, liver, small bowel, or colon, comprising:
 a film having a thickness from about 2 μm to about 1000 μm and comprising a mixture of a degradable polymer and a chemotherapeutic drug,   wherein the device is configured for deployment into a tissue site of a patient, the film being configured to provide controlled release, by in vivo degradation of the polymer at the tissue site, of a therapeutically effective amount of the chemotherapeutic drug to the tissue site to treat the tumor.   
     
     
         2 . The device of  claim 1 , wherein the release of the therapeutically effective amount of the chemotherapeutic drug follows a delay period of from about 1 day to about 14 days after deploying of the device into the tissue site. 
     
     
         3 . The device of  claim 2 , wherein the release of the therapeutically effective amount of the chemotherapeutic drug, after the delay period, has an initial release rate that is substantially linear for at least  3  days. 
     
     
         4 . The device of  claim 1 , wherein the degradable polymer is a hydrolytically degradable polymer. 
     
     
         5 . The device of  claim 1 , wherein the degradable polymer comprises poly(lactic-co-glycolic acid). 
     
     
         6 . The device of  claim 1 , wherein the chemotherapeutic drug is selected from the group consisting of paclitaxel, gemcitabine, nab-paclitaxel, 5-fluorouracil, oxaliplatin, irinotecan, and combinations thereof. 
     
     
         7 . The device of  claim 1 , wherein the chemotherapeutic drug is paclitaxel and the degradable polymer is poly(lactic-co-glycolic acid). 
     
     
         8 . The device of  claim 7 , wherein the therapeutically effective amount is at least 1 mg/day of the paclitaxel. 
     
     
         9 . The device of  claim 7 , wherein the therapeutically effective amount of paclitaxel is released over a treatment period from about 10 days to about 90 days. 
     
     
         10 . The device of  claim 7 , wherein the therapeutically effective amount comprises a mean average amount of from 5 mg/day to 125 mg /day of the paclitaxel. 
     
     
         11 . The device of  claim 1 , wherein the film has a thickness from about 5 μm to about 500 μm. 
     
     
         12 . The device of  claim 1 , wherein the mixture comprises from about 1 wt % to about 10 wt % of paclitaxel or another chemotherapeutic agent. 
     
     
         13 . The device of  claim 1 , wherein the device further comprises a biocompatible substratum to which the film is adhered. 
     
     
         14 . The device of  claim 13 , wherein the substratum comprises a stent, and wherein the device is configured for insertion into a biliary or pancreatic duct of the patient. 
     
     
         15 . The device of  claim 13 , wherein the substratum comprises a flexible patch, a rigid patch, or a mesh, and wherein the device is configured to be implanted directly onto the tumor. 
     
     
         16 . The device of  claim 13 , wherein the substratum comprises a metal, a polymer, or a ceramic material. 
     
     
         17 . The device of  claim 13 , wherein the substratum comprises stainless steel alloy, cobalt chromium alloy, nitinol, platinum alloy, titanium alloy, silicone, expanded polytetrafluoroethylene (ePTFE), or polyethylene.