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Claims for Patent: 8,268,348

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Claims for Patent: 8,268,348

Title:Combinations and modes of administration of therapeutic agents and combination therapy
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.
Inventor(s): Desai; Neil P. (Los Angeles, CA), Soon-Shiong; Patrick (Los Angeles, CA)
Assignee: Abraxis Bioscience, LLC (Los Angeles, CA)
Application Number:13/228,323
Patent Claims: 1. A method for treating non-small cell lung cancer (NSCLC) in a human individual comprising intravenously administering to the individual: a) an effective amount of a composition comprising nanoparticles comprising paclitaxel coated with albumin, and b) an effective amount of carboplatin, wherein the nanoparticle composition is free of cremophor.

2. The method of claim 1, wherein dosage of paclitaxel in the nanoparticle composition is about 50 to about 400 mg/m.sup.2.

3. The method of clam 2, wherein the nanoparticle composition is administered on a weekly schedule and the dosage of paclitaxel in the nanoparticle composition is in the range of 50-250 mg/m.sup.2.

4. The method of claim 3, wherein the nanoparticle composition is administered on a weekly schedule and the dosage of paclitaxel in the nanoparticle composition is in the range of 100-150 mg/m.sup.2.

5. The method of claim 4, wherein the carboplatin is administered once every three weeks.

6. The method of claim 5, wherein the carboplatin is administered at the dose of AUC=6.

7. The method of claim 6, wherein the NSCLC is advanced.

8. The method of claim 7, wherein the NSCLC is first line advanced NSCLC.

9. The method of claim 6, wherein the average diameter of the nanoparticles in the composition is no greater than about 200 nm.

10. The method of claim 6, wherein the albumin is human serum albumin.

11. The method of claim 10, wherein the weight ratio of the albumin and paclitaxel in the nanoparticle composition is about 9:1 or less.

12. The method of claim 11, wherein the weight ratio of the albumin and paclitaxel in the nanoparticle composition is about 9:1.

13. The method of claim 4, wherein the NSCLC is advanced.

14. The method of claim 13, wherein the NSCLC is first line advanced NSCLC.

15. The method of claim 14, wherein the average diameter of the nanoparticles in the composition is no greater than about 200 nm.

16. The method of claim 4, wherein the average diameter of the nanoparticles in the composition is no greater than about 200 nm.

17. The method of claim 4, wherein the albumin is human serum albumin.

18. The method of claim 17, wherein the weight ratio of the albumin and paclitaxel in the nanoparticle composition is about 9:1 or less.

19. The method of claim 18, wherein the weight ratio of the albumin and paclitaxel in the nanoparticle composition is about 9:1.

20. The method of claim 1, wherein the carboplatin is administered once every three weeks.

21. The method of claim 20, wherein the carboplatin is administered at the dose of AUC=6.

22. The method of claim 1, wherein the nanoparticle composition is administered on a weekly schedule and the dosage of paclitaxel in the nanoparticle composition is 100 mg/m.sup.2, and the carboplatin is administered once every three weeks and at the dose of AUC=6.

23. The method of claim 22, wherein the NSCLC is advanced.

24. The method of claim 23, wherein the NSCLC is first line advanced NSCLC.

25. The method of claim 24, wherein the average diameter of the nanoparticles in the composition is no greater than about 200 nm.

26. The method of claim 24, wherein the albumin is human serum albumin.

27. The method of claim 26, wherein the weight ratio of the albumin and paclitaxel in the nanoparticle composition is about 9:1 or less.

28. The method of claim 27, wherein the weight ratio of the albumin and paclitaxel in the nanoparticle composition is about 9:1.

29. The method of claim 22, wherein the average diameter of the nanoparticles in the composition is no greater than about 200 nm.

30. The method of claim 1, wherein the NSCLC is advanced.

31. The method of claim 30, wherein the NSCLC is first line advanced NSCLC.

32. The method of claim 1, wherein the average diameter of the nanoparticles in the composition is no greater than about 200 nm.

33. The method of claim 1, wherein the albumin is human serum albumin.

34. The method of claim 33, wherein the weight ratio of the albumin and paclitaxel in the nanoparticle composition is about 9:1 or less.

35. The method of claim 34, wherein the weight ratio of the albumin and paclitaxel in the nanoparticle composition is about 9:1.

36. A method for treating non-small cell lung cancer (NSCLC) in a human individual comprising intravenously administering to the individual: a) an effective amount of a composition comprising nanoparticles comprising paclitaxel coated with human serum albumin, wherein the nanoparticle composition is free of cremophor, wherein the average diameter of the nanoparticles in the composition is no greater than about 200 nm, wherein the nanoparticle composition is administered on a weekly schedule and the dosage of paclitaxel in the nanoparticle composition is 100 mg/m2, and b) an effective amount of carboplatin, wherein the carboplatin is administered once every three weeks and at the dose of AUC=6.

37. The method of claim 36, wherein the weight ratio of the human serum albumin and paclitaxel in the nanoparticle composition is about 9:1 or less.

38. The method of claim 37, wherein the weight ratio of the human serum albumin and paclitaxel in the nanoparticle composition is about 9:1.

39. The method of claim 36, wherein the NSCLC is advanced.

40. The method of claim 39, wherein the NSCLC is first line advanced NSCLC.

41. The method of claim 40, wherein the weight ratio of the human serum albumin and paclitaxel in the nanoparticle composition is about 9:1 or less.

42. The method of claim 41, wherein the weight ratio of the human serum albumin and paclitaxel in the nanoparticle composition is about 9:1.
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