Claims
- 1. A method of treating a patient suffering form cancer, comprising administering to the patient a therapeutically effective amount of a combination of a first component consisting of pharmaceutical composition containing as an active ingredient a compound of formula I
- 2. The method of claim 1, wherein both components are administered concomitantly.
- 3. The method of claim 1, wherein both components are administered sequentially.
- 4. The method of claim 1 wherein the amount of compound of formula I in the combination is not by itself a therapeutically effective amount.
- 5. The method of claim 1 wherein the amount of gemcitabine I in the combination is not by itself a therapeutically effective amount.
- 6. The method of claim 1, wherein the pharmaceutical composition of the first component is an oral unit dosage form.
- 7. The method of claim 6, wherein the active ingredient of the first component is a compound of the formula:
- 8. The method of claim 6, wherein the active ingredient of the first component is a compound of the formula
- 9. The method of claim 6, wherein the active ingredient of the first component is a compound of the formula
- 10. The method of claim 1 wherein the amount of a compound of formula I is from about 1040 mg/m2 to about 3000 mg/m2 administered over a period of up to about 14 days.
- 11. The method of claim 10 wherein the amount of a compound of formula I is from about 1480 mg/m2 to about 2360 mg/m2.
- 12. The method of claim 1 wherein the amount of a compound of formula I is from about 1040 mg/m2 to about 3000 mg/m2 over a period of about 7 days.
- 13. The method of claim 12 wherein the amount of a compound of formula I is from about 1480 mg/m2 to about 2360 mg/m2.
- 14. The method of claim 1 wherein the amount of a compound of formula I is from about 1780 mg/m2 to about 2250 mg/m2 over a period of about 4 days.
- 15. The method of claim 14 wherein the amount of a compound of formula I is from about 1110 mg/m2 to about 1770 mg/m2 over a period of about 4 days.
- 16. The method of claim 1 wherein the dose intensity of the compound of formula I is from about 260 mg/m2/week to about 750 mg/m2/week.
- 17. The method of claim 16 wherein the dose intensity of the compound of formula I is from about 370 mg/m2/week to about 590 mg/m2/week.
- 18. The method of claim 1 wherein the active ingredient of the second component is gemcitabine.
- 19. The method of claim 18 wherein the amount of gemcitabine is from about 1200 mg/m2 to about 2400 mg/m2 administered over a period of up to about 8 days.
- 20. The method of claim 19 wherein the amount of gemcitabine is from about 1600 mg/m2 to about 2000 mg/m2 administered over a period of up to about 8 days.
- 21. The method of claim 1 wherein the amount of gemcitabine is from about 1800 mg/m2 to about 3600 administered over a period of up to about 15 days.
- 22. The method of claim 21 wherein the amount of gemcitabine is from about 2400 mg/m2 to about 300 administered over a period of up to about 15 days.
- 23. The method of claim 18 wherein the gemcitabine is administered on days 1 and 8 of a 21-day treatment cycle.
- 24. The method of claim 23 wherein the dose intensity of gemcitabine is from about 460 mg/m2/week to about 800 mg/m2/week.
- 25. The method of claim 24 wherein the dose intensity of gemcitabine is from about 530 mg/m2/week to about 670 mg/m2/week.
- 26. The method of claim 20 wherein the gemcitabine is administered on days 1 and 8 of a 21-28 day treatment cycle.
- 27. The method of claim 21 wherein the gemcitabine is administered on days 1, 8 and 15 of a 28-day treatment cycle.
- 28. A method of treating a patient suffering with cancer comprising administering to the patient:
(i) a first component consisting of pharmaceutical composition containing as an active ingredient a compound of formula: 10or a pharmaceutically acceptable salt or ester of said compound, wherein the compound of formula II is administered in an amount of from about 70 mg/m2 per day to about 220 mg/m2 per day for up to about 14 days starting on the first day of a 28 day cycle, and (ii) a second component consisting of an injection solution containing as an active ingredient gemcitabine which is administered in amount of from about 800 mg/m2 to about 1000 mg/m2 on the first, eighth and fifteenth day of a 28 day cycle, said 28 day cycle being repeated as long as the tumor remains under control.
- 29. A method of treating a patient suffering with cancer comprising administering to the patient:
(i) a first component consisting of pharmaceutical composition containing as an active ingredient a compound of formula: 11or a pharmaceutically acceptable salt or ester of said compound, wherein the compound of formula II is administered in an amount of from about 200 mg/m2 per day to about 340 mg/m2 per day for up to about 7 days starting on the first day of a 28 day cycle, and (ii) a second component consisting of an injection solution containing as an active ingredient gemcitabine which is administered in amount of from about 600 mg/m2 to about 1200 mg/m2 on the first and eighth day of a 28 day cycle, and said 28 day cycle being repeated as long as the tumor remains under control.
- 30. A method of treating a patient suffering with cancer comprising administering to the patient:
(i) a first component consisting of pharmaceutical composition containing as an active ingredient a compound of formula: 12or a pharmaceutically acceptable salt or ester of said compound, wherein the compound of formula II is administered in an amount of from about 270 mg/m2 per day to about 450 mg/m2 per day for up to about 4 days starting on the first day of a 21 day cycle, and (ii) a second component consisting of an injection solution containing as an active ingredient gemcitabine which is administered in amount of from about 800 mg/m2 to about 1000 mg/m2 on the first and eighth day of a 21 day cycle, and said 21 day cycle being repeated as long as the tumor remains under control.
- 31. A method of treating a patient suffering with cancer comprising administering to the patient:
(i) a first component consisting of pharmaceutical composition containing as an active ingredient a compound of formula: 13or a pharmaceutically acceptable salt or ester of said compound, wherein the compound of formula II is administered in an amount of from about 190 mg/m2 per day to about 570 mg/m2 per day for up to about 4 days starting on the first day of a 21 day cycle, and (ii) a second component consisting of an injection solution containing as an active ingredient gemcitabine which is administered in amount of from about 700 mg/m2 to about 1200 mg/m2 on the first and eighth day of a 21 day cycle, said 21 day cycle being repeated as long as the tumor remains under control.
- 32. A kit comprising:
(a) a first component containing one or more oral unit dosage forms of an active ingredient, each unit containing about 50 mg to about 200 mg of the active ingredient, wherein the active ingredient is a compound selected from formula I 14or a pharmaceutically acceptable salt or ester said compound, wherein
R1 is selected from the group consisting of —H, —CH3, and —CH2OH, and R2 is —CH3; and (b) a second component containing a vial or series of vials, each vial containing a single injectable solution dose or multiple injectable solution doses, each dose containing as an active ingredient about 200 mg to about 1 g of gemcitabine.
- 33. The kit of claim 30, wherein the first component contains a sufficient number of units so that a patient can administer about 600 mg per day of the compound of formula I or a pharmaceutically acceptable salt or ester of said compound for a period of about 4 to about 14 days and the second component contains a sufficient number of doses so that a patient can administer about 2600 mg per day of gemcitabine for a period of about three days.
- 34. The kit of claim 33 wherein the active ingredient of the first component is
- 35. The kit of claim 33, wherein the active ingredient of the first component is
- 36. The kit of claim 33, wherein the active ingredient of the first component is a compound of the formula
- 37. The method of claim 1 comprising additionally subjecting the patient to radiotherapy.
Parent Case Info
[0001] This application claims priority of Provisional application Serial No. 60/333,977, filed Nov. 20, 2001.
Provisional Applications (1)
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Number |
Date |
Country |
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60333977 |
Nov 2001 |
US |