Cancer Treatment Useing Docetaxel by Controlling Peak Plasma Levels

Abstract

Treatments of cancers involve a wide range of treatment. The current invention relates to chemotherapy of tumors using taxanes, in particular docetaxel. More in particular it relates to a method for the treatment of a cancer in a patient comprising orally administering an effective dose of docetaxel, whereby side effects are controlled by preventing peak plasma levels of docetaxel that induce said side effects, whilst maintaining an effective plasma level of docetaxel to eradicate tumor cells.

1 . A method for the treatment of a cancer in a patient comprising orally administering an effective dose of docetaxel, whereby side effects are controlled by preventing peak plasma levels of docetaxel that induce said side effects, whilst maintaining an effective plasma level of docetaxel to eradicate tumor cells. 
     
     
         2 . A method for reducing side effects of the treatment of a cancer in a patient, the method comprising administering docetaxel, wherein said docetaxel is administered orally, and controlling side effects by preventing peak plasma levels of docetaxel that induce said side effects, whilst maintaining an effective plasma level of docetaxel to eradicate tumor cells. 
     
     
         3 . The method according to  claim 1  wherein the dose limiting side effect is neutropenia. 
     
     
         4 . The method according to  claim 1  wherein the plasma levels of docetaxel are at least partially controlled by administering a CYP3A inhibitor. 
     
     
         5 . The method according to  claim 4 , wherein said CYP3A4 inhibitor is ritonavir. 
     
     
         6 . The method according to  claim 4 , wherein said CYP3A inhibitor is simultaneously administered. 
     
     
         7 . The method according to  claim 1 , wherein said treatment of cancer comprises an extended use of more than 30 weeks. 
     
     
         8 . The method according to  claim 1 , wherein the peak plasma levels of docetaxel are below 3000 ng/mL. 
     
     
         9 . The method according to  claim 1 , wherein effective plasma level of docetaxel is at least 800 ng·h/mL. 
     
     
         10 . The method according to  claim 1 , wherein the cancer is a solid tumor. 
     
     
         11 . The method according to  claim 1 , wherein docetaxel is administered weekly. 
     
     
         12 . The method according to any one of  claim 11 , wherein docetaxel is administered at a dosage of at least 50 mg bidaily weekly. 
     
     
         13 . (canceled) 
     
     
         14 . (canceled) 
     
     
         15 . (canceled) 
     
     
         16 . The method according to  claim 2 , wherein said peak plasma levels of docetaxel are at most 3000 ng/ml. 
     
     
         17 . The method according to  claim 2 , wherein said peak plasma levels of docetaxel have an area under the curve of at least 800 ng·h/ml. 
     
     
         18 . The method according to  claim 2 , wherein said treatment lasts for more than 30 weeks. 
     
     
         19 . The method according to  claim 2 , wherein the cancer is a solid tumor. 
     
     
         20 . The method according to  claim 4 , wherein said CYP3A inhibitor is ritonavir. 
     
     
         21 . The method according to  claim 2 , wherein the cancer is selected from the group consisting of consisting of gastric cancer, breast cancer, head and neck cancer, lung cancer and prostate cancer. 
     
     
         22 . A kit comprising a pharmaceutical composition for oral administration comprising docetaxel and a pharmaceutical composition comprising a CYP3A inhibitor. 
     
     
         23 . The kit according to  claim 22  for use in:
 performing a method, comprising orally administering an effective dose of docetaxel, whereby side effects are controlled by preventing peak plasma levels of docetaxel that induce said side effects, whilst maintaining an effective plasma level of docetaxel to eradicate tumor cells; and/or 
 performing a method comprising administering docetaxel, wherein said docetaxel is administered orally, and controlling side effects by preventing peak plasma levels of docetaxel that induce said side effects, whilst maintaining an effective plasma level of docetaxel to eradicate tumor cells.