Method for treating taxol side-effects with G-CSF

Abstract

A method of treating a host using taxol comprising administering granulocyte colony-stimulating factor to the host being treated with taxol. The present inventive method allows for increased levels of taxol to be administered to the host in the treatment of various conditions, particularly with respect to ovarian tumors.

What is claimed is:  
     
       1. A method of treating a host being treated with taxol in an amount sufficient to cause a side effect selected from the group consisting of myelosuppression, mucositis, and peripheral neuropathy, which method comprises administering to said host granulocyte colony-stimulating factor in an amount effective to alleviate or prevent said side effect. 
     
     
       2. The method of  claim 1 , wherein said host is being treated with taxol in an amount exceeding about 175 mg/m 2 / 21 days. 
     
     
       3. A method of  claim 1 , wherein said side effect is myelosuppression or mucositis. 
     
     
       4. The method of  claim 3 , wherein said granulocyte colony-stimulating factor is administered in an amount of at least about 5 μg/kg/day. 
     
     
       5. The method of  claim 4 , wherein said granulocyte colony-stimulating factor is administered in an amount of about 10 to about 20 μg/kg/day. 
     
     
       6. The method of  claim 1 , wherein said host is being treated with taxol once every three weeks and said granulocyte colony-stimulating factor is administered daily for at least seven days following the taxol treatment. 
     
     
       7. The method of  claim 6  wherein said host is being treated with taxol in an amount of about 200 to about 250 mg/m 2 / 21 days. 
     
     
       8. The method of  claim 1 , wherein said host is being treated with taxol to treat a cancerous tumor. 
     
     
       9. The method of  claim 8 , wherein said cancerous tumor is a breast, lung or ovarian tumor. 
     
     
       10. The method of  claim 9 , wherein said cancerous tumor is an ovarian tumor. 
     
     
       11. The method of  claim 10 , wherein said host is being treated with taxol in an amount exceeding about 175 mg/m 2 / 21 days. 
     
     
       12. The method of  claim 11 , wherein said granulocyte colony-stimulating factor is administered in an amount of at least about 5 μg/kg/day. 
     
     
       13. The method of  claim 12 , wherein said granulocyte colony-stimulating factor is administered in an amount of about 10 to about 20 μg/kg/day. 
     
     
       14. The method of  claim 13 , wherein said host is being treated with taxol once every three weeks and said granulocyte colony-stimulating factor is administered daily for at least seven days following the taxol treatment. 
     
     
       15. The method of  claim 14 , wherein said host is being treated with taxol in an amount of about 200 to about 250 mg/m 2 / 21 days. 
     
     
       16. A method of treating a host being treated with taxol in an amount sufficient to cause mucositis, which method comprises administering to said host granulocyte colony- stimulating factor  ( G - CSF )  in an amount effective to alleviate or prevent mucositis.   
     
     
       17. The method of  claim 16 , wherein said host is being treated with taxol in an amount exceeding about  175  mg/m 2   / 21  days.   
     
     
       18. The method of  claim 16 , wherein said G- CSF is administered in an amount of at least about  5  μg/kg/day.   
     
     
       19. The method of  claim 18 , wherein said G- CSF is administered in an amount of about  10  to about  20  μg/kg/day.   
     
     
       20. The method of  claim 16 , wherein said host is being treated with taxol once every three weeks and said G- CSF is administered daily for at least seven days following the taxol treatment.   
     
     
       21. The method of  claim 20 , wherein said host is being treated with taxol in an amount of about  200  to about  250  mg/m 2   / 21  days.   
     
     
       22. The method of  claim 16 , wherein said host is being treated with taxol to treat a cancerous tumor. 
     
     
       23. The method of  claim 22 , wherein said cancerous tumor is a breast, lung or ovarian tumor. 
     
     
       24. The method of  claim 23 , wherein said host is being treated with taxol in an amount exceeding about  175  mg/m 2   / 21  days.   
     
     
       25. The method of  claim 24 , wherein said G- CSF is administered in an amount of at least about  5  μg/kg/day.   
     
     
       26. The method of  claim 25 , wherein said G- CSF is administered in an amount of about  10  to about  20  μg/kg/day.   
     
     
       27. The method of  claim 26 , wherein said host is being treated with taxol once every three weeks and said G- CSF is administered daily for at least seven days following the taxol treatment.   
     
     
       28. The method of  claim 27 , wherein said host is being treated with taxol in an amount of about  200  to about  250  mg/m 2   / 21  days.   
     
     
       29. A method of treating a host being treated with taxol in an amount sufficient to cause peripheral neuropathy, which method comprises administering to said host granulocyte colony- stimulating factor  ( G - CSF )  in an amount effective to alleviate or prevent peripheral neuropathy.   
     
     
       30. The method of  claim 29 , wherein said host is being treated with taxol in an amount exceeding about  175  mg/m 2   / 21  days.   
     
     
       31. The method of  claim 29 , wherein said G- CSF is administered in an amount of at least about  5  μg/kg/day.   
     
     
       32. The method of  claim 31 , wherein said G- CSF is administered in an amount of about  10  to about  20  μg/kg/day.   
     
     
       33. The method of  claim 29 , wherein said host is being treated with taxol once every three weeks and said G- CSF is administered daily for at least seven days following the taxol treatment.   
     
     
       34. The method of  claim 33 , wherein said host is being treated with taxol in an amount of about  200  to about  250  mg/m 2   / 21  days.   
     
     
       35. The method of  claim 29 , wherein said host is being treated with taxol to treat a cancerous tumor. 
     
     
       36. The method of  claim 35 , wherein said cancerous tumor is a breast, lung or ovarian tumor. 
     
     
       37. The method of  claim 36 , wherein said host is being treated with taxol in an amount exceeding about  175  mg/m 2   / 21  days.   
     
     
       38. The method of  claim 37 , wherein said G- CSF is administered in an amount of at least about  5  μg/kg/day.   
     
     
       39. The method of  claim 38 , wherein said G- CSF is administered in an amount of about  10  to about  20  μg/kg/day.   
     
     
       40. The method of  claim 39 , wherein said host is being treated with taxol once every three weeks and said G- CSF is administered daily for at least seven days following the taxol treatment.   
     
     
       41. The method of  claim 40 , wherein said host is being treated with taxol in an amount of about  200  to about  250  mg/m 2   / 21  days.   
     
     
       42. A method of treating a host being treated with taxol in an amount sufficient to cause thrombocytopenia, which method comprises administering to said host G- CSF in an amount effective to alleviate or prevent thrombocytopenia.   
     
     
       43. The method of  claim 42 , wherein said host is being treated with taxol in an amount exceeding about  175  mg/m 2   / 21  days.   
     
     
       44. The method of  claim 42 , wherein said G- CSF is administered in an amount of at least about  5  μg/kg/day.   
     
     
       45. The method of  claim 44 , wherein said G- CSF is administered in an amount of about  10  to about  20  μg/kg/day.   
     
     
       46. The method of  claim 42 , wherein said host is being treated with taxol once every three weeks and said G- CSF is administered daily for at least seven days following the taxol treatment.   
     
     
       47. The method of  claim 46 , wherein said host is being treated with taxol in an amount of about  200  to about  250  mg/m 2   / 21  days.   
     
     
       48. The method of  claim 42 , wherein said host is being treated with taxol to treat a cancerous tumor. 
     
     
       49. The method of  claim 48 , wherein said cancerous tumor is a breast, lung or ovarian tumor. 
     
     
       50. The method of  claim 49 , wherein said host is being treated with taxol in an amount exceeding about  175  mg/m 2   / 21  days.   
     
     
       51. The method of  claim 50 , wherein said G- CSF is administered in an amount of at least about  5  μg/kg/day.   
     
     
       52. The method of  claim 51 , wherein said G- CSF is administered in an amount of about  10  to about  20  μg/kg/day.   
     
     
       53. The method of  claim 52 , wherein said host is being treated with taxol once every three weeks and said G- CSF is administered daily for at least seven days following the taxol treatment.   
     
     
       54. The method of  claim 53 , wherein said host is being treated with taxol in an amount of about  200  to about  250  mg/m 2   / 21  days.   
     
     
       55. A method of treating a host being treated with taxol in an amount sufficient to cause a side effect selected from the group consisting of myelosuppression, mucositis, and peripheral neuropathy, wherein G- CSF is administered to said host in a cycle of therapy with taxol and said host develops a side effect, which method comprises administering G - CSF to said host in a subsequent cycle of taxol therapy in an amount effective to alleviate or prevent said side effect.   
     
     
       56. The method of  claim 55 , wherein taxol is administered at a dosage level of about  250  mg/m 2   /day.   
     
     
       57. The method of  claim 56 , wherein, in said cycle of therapy with taxol, about  10  μg/kg/day of G- CSF is administered.   
     
     
       58. The method of  claim 57 , wherein, in said subsequent cycle of therapy with taxol, about  10 - 20  μg/kg/day of G- CSF is administered.   
     
     
       59. The method of  claim 58 , wherein, in said subsequent cycle of therapy with taxol, about  15 - 20  μg/kg/day of G- CSF is administered.   
     
     
       60. The method of  claim 58 , wherein said method comprises another subsequent cycle of taxol therapy and in said another subsequent cycle of taxol therapy, said host develops a side effect and the amount of taxol used to treat said host is reduced. 
     
     
       61. The method of  claim 60 , wherein the amount of taxol is about  200  mg/m 2   /kg.   
     
     
       62. The method of  claim 59 , wherein said method comprises another subsequent cycle of taxol therapy and in said another subsequent cycle of taxol therapy, said host develops a side effect and the amount of taxol used to treat said host is reduced. 
     
     
       63. The method of  claim 62 , wherein the amount of taxol is about  200  mg/m 2   /kg.   
     
     
       64. The method of  claim 55 , wherein said myelosuppression is neutropenia. 
     
     
       65. The method of  claim 64 , wherein said neutropenia is febrile.