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Claims for Patent: 8,034,375

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Claims for Patent: 8,034,375

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. (Santa Monica, CA), Soon-Shiong; Patrick (Los Angeles, CA)
Assignee: Abraxis Bioscience, LLC (Los Angeles, CA)
Application Number:11/359,286
Patent Claims: 1. A method of treating non-small cell lung cancer (NSCLC) in a human individual comprising administering to the individual: a) an effective amount of a composition comprising nanoparticles comprising paclitaxel coated with albumin, and b) an effective amount of a platinum-based agent, wherein the platinum-based agent is cisplatin or carboplatin, and wherein the nanoparticle composition is free of cremophor.

2. The method according to claim 1, wherein said platinum-based agent is carboplatin.

3. The method according to claim 1, wherein the composition comprising nanoparticles comprising paclitaxel coated with albumin and the platinum-based agent are administered simultaneously.

4. The method according to claim 1, wherein the composition comprising nanoparticles comprising paclitaxel coated with albumin and the platinum-based agent are administered sequentially.

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

6. The method according to claim 5, wherein the weight ratio of the albumin and paclitaxel in the nanoparticle composition is less than about 9:1.

7. The method according to claim 5, wherein the platinum-based agent is carboplatin.

8. The method according to claim 1, wherein the albumin is human serum albumin.

9. The method of claim 1, wherein the cancer is an advanced stage cancer.

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

11. The method of claim 1, wherein the nanoparticle composition is administered on a three week schedule and the dosage of paclitaxel in the nanoparticle composition is in the range of 100-400 mg/m.sup.2.

12. 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 in the range of 50-250 mg/m.sup.2.

13. The method of claim 1, wherein the nanoparticle composition is administered on a three week schedule and the dosage of paclitaxel in the nanoparticle composition is in the range of 220-340 mg/m.sup.2.

14. The method of claim 13, wherein the platinum-based agent is carboplatin.

15. 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 in the range of 100-150 mg/m.sup.2.

16. The method of claim 1, wherein the interval between each administration of the nanoparticle composition is no more than about a week.

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

18. The method of claim 5, wherein the weight ratio of the albumin and paclitaxel in the nanoparticle composition is about 18:1 or less.

19. The method of claim 5, wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1 or less.

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

21. The method of claim 20, wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 18:1 or less.

22. The method of claim 21, wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1 or less.

23. The method of claim 22, wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is less than about 9:1.

24. The method of claim 19, wherein the platinum-based agent is carboplatin, and wherein the albumin is human serum albumin.

25. The method of claim 15, wherein the cancer is an advanced stage cancer.

26. The method of claim 15, wherein the dosage of paclitaxel in the nanoparticle composition is about 100 mg/m.sup.2.

27. The method of claim 26, wherein the average diameter of the nanoparticles in the composition is no greater than about 200 nm.

28. The method of claim 27, wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 18:1 or less.

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

30. The method of claim 29, wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is less than about 9:1.

31. The method of claim 18, wherein the platinum-based agent is carboplatin.

32. The method of claim 26, wherein the cancer is an advanced stage cancer.

33. The method of claim 1, wherein the platinum-based agent is cisplatin.

34. The method of claim 20, wherein the platinum-based agent is carboplatin.
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