Methods and formulations of taxanes

Abstract

In accordance with the present invention, there are provided compositions and methods useful for the in vivo delivery of a pharmaceutically active agent, wherein the agent is associated with a polymeric biocompatible material.

1 . A unit dosage form comprising a sealed vial containing a sufficient quantity of cremophor-free taxane to provide for administration to a human subject a total dose of taxane in the range of about 30 mg/m 2  to about 1000 mg/m 2  over an administration period no greater than about 3 hours, wherein the cycle time between administrations of said total dose is less than about three weeks.  
   
   
       2 . A unit dosage form according to  claim 1 , wherein said total dose is in the range of about 50 mg/m to about 700 mg/m 2 .  
   
   
       3 . A unit dosage form according to  claim 1 , wherein said total dose is in the range of about 175 mg/m 2  to about 300 mg/m 2 .  
   
   
       4 . A unit dosage form according to  claim 1 , wherein said taxane is administered locally.  
   
   
       5 . A unit dosage form according to  claim 1 , wherein said taxane is administered systemically.  
   
   
       6 . A unit dosage form according to  claim 1 , wherein said taxane is in a non-aqueous formulation.  
   
   
       7 . A unit dosage form according to  claim 1 , wherein said taxane is docetaxel.  
   
   
       8 . A unit dosage form according to  claim 1 , wherein said taxane is a paclitaxel analog.