Methods and compositions for treating proliferative diseases

Abstract

The present invention provides combination therapy methods of treating proliferative diseases (such as cancer) comprising a first therapy comprising administering to an individual an effective amount of a taxane in a nanoparticle composition, and a second therapy which may include, for example, radiation, surgery, administration of chemotherapeutic agents, or combinations thereof. Also provided are methods of administering to an individual a drug taxane in a nanoparticle composition based on a metronomic dosing regime.

1 - 16 . (canceled) 
     
     
         17 . A method of treating a proliferative disease in an individual, comprising administering to the individual a) an effective amount of a composition comprising nanoparticles comprising a taxane and a carrier protein and b) an anthracycline antibiotic. 
     
     
         18 . The method of  claim 17 , wherein the anthracycline antibiotic is selected from the group consisting of epirubicin, Doxil, actinomycin, dactinomycin, daunorubicin, doxorubicin, idarubicin, mitoxantrone, and valrubicin. 
     
     
         19 . The method of  claim 17 , wherein the anthracycline antibiotic is epirubicin. 
     
     
         20 . The method of  claim 17 , wherein the taxane is paclitaxel. 
     
     
         21 . The method of  claim 19 , wherein the taxane is paclitaxel. 
     
     
         22 . The method of  claim 17 , wherein the average diameter of the nanoparticles in the composition is no greater than 200 nm. 
     
     
         23 . The method of  claim 21 , wherein the average diameter of the nanoparticles in the composition is no greater than 200 nm. 
     
     
         24 . The method of  claim 17 , where the average diameter of the nanoparticles in the composition is no greater than 150 nm. 
     
     
         25 . The method of  claim 20 , wherein the carrier protein is albumin. 
     
     
         26 . The method of  claim 25 , wherein the albumin is human serum albumin. 
     
     
         27 . The method of  claim 25 , wherein the weight ratio of the albumin and the paclitaxel in the nanoparticle composition is about 9:1 or less. 
     
     
         28 . The method of  claim 21 , wherein the carrier protein is albumin and wherein the weight ratio of the albumin and the paclitaxel in the nanoparticle composition is about 9:1 or less. 
     
     
         29 . The method of  claim 27 , wherein the paclitaxel is coated with albumin. 
     
     
         30 . The method of  claim 17 , wherein the individual is human. 
     
     
         31 . The method of  claim 17 , wherein the proliferative disease is cancer. 
     
     
         32 . The method of  claim 31 , wherein the cancer is breast cancer. 
     
     
         33 . The method of  claim 32 , wherein the method is for treatment of breast cancer in a neoadjuvant setting. 
     
     
         34 . The method of  claim 32 , wherein the method is for treatment of an early stage breast cancer. 
     
     
         35 . The method of  claim 17 , wherein the nanoparticle composition is administered on a three week schedule and the dosage of the taxane in the nanoparticle composition is in the range of 100 to 400 mg/m 2 . 
     
     
         36 . The method of  claim 17 , wherein the nanoparticle composition and the anthracycline antibiotic are administered sequentially. 
     
     
         37 . The method of  claim 17 , further comprising administering an effective amount of cyclophosphamide to the individual.