Method for administration

Abstract

There is provided a new dosage regimen for Compound A which maximizes anti-tumor activity while maintaining acceptable toxicity levels.

What is claimed: 
     
         1 . A method of treating a patient suffering from cancer, comprising administering to said patient a pharmaceutical composition containing as an active ingredient Compound A in an amount from about 400 mg/day to about 1600 mg/day, daily, for up to about 7 days, followed by a rest period of about 21 days, said administration starting on the first day of a 28 day treatment cycle. 
     
     
         2 . A method of treating a patient suffering from cancer, comprising administering to said patient a pharmaceutical composition containing as an active ingredient Compound A in an amount from about 400 mg/day to about 1600 mg/day, daily, for up to about 5 days, followed by a rest period of about 23 days, said administration starting on the first day of a 28 day treatment cycle. 
     
     
         3 . The method of  claim 2  wherein Compound A is administered in an amount from about 400 mg/day to about 1200 mg/day. 
     
     
         4 . The method of  claim 1  wherein the treatment cycle being repeated every 28 days for up to about 12 cycles. 
     
     
         5 . The method of  claim 1  wherein Compound A is administered twice daily in equal doses. 
     
     
         6 . The method of  claim 1  wherein the cancer is selected from the group consisting of colon, breast, prostate, head, neck, lung, kidney, leukemia, melanoma, soft tissue sarcoma and osteosarcoma. 
     
     
         7 . The method of  claim 2 , comprising administering to said patient a pharmaceutical composition containing as an active ingredient Compound A at about 500 mg/day total, daily for up to about 5 days, followed by a rest period of about 23 days, said administration starting on the first day of a 28 day treatment cycle. 
     
     
         8 . The method of  claim 7  wherein the cancer is selected from the group consisting of colon, breast, prostate, head, neck, lung, kidney, melanoma, soft tissue sarcoma and osteosarcoma. 
     
     
         9 . A method of treating a patient suffering from leukemia, comprising administering to said patient a pharmaceutical composition containing as an active ingredient Compound A at about 1200 mg/day total daily, for up to about 5 days, followed by a rest period of about 23 days, said administration starting on the first day of a 28 day treatment cycle. 
     
     
         10 . A method of treating a patient suffering from cancer, comprising administering to said patient a pharmaceutical composition containing as an active ingredient Compound A in an amount of about 400-1000 mg total daily dose for up to 3 days followed by a rest period of up to about 25 days, said administration starting on the first day of a 28 day treatment cycle. 
     
     
         11 . The method of  claim 10  wherein the cancer is selected from the group consisting of colon, breast, prostate, head, neck, lung, kidney, leukemia, melanoma, soft tissue sarcoma and osteosarcoma.