Methods of treatment of pancreatic cancer

Patent metadata

Field	Value
Publication number	US-9820949-B2
Application number	US-201615192077-A
Country	US
Kind code	B2
Filing date	Jun 24, 2016
Priority date	Jun 4, 2010
Publication date	Nov 21, 2017
Grant date	Nov 21, 2017

Abstract

The present invention provides methods and compositions for treating pancreatic cancer in an individual who has been previously treated for pancreatic cancer (e.g., gemcitabine-based therapy) by administering a composition comprising nanoparticles that comprise a taxane and an albumin. The invention also provides combination therapy methods of treating pancreatic cancer (for example, in an individual who has been previously treated for pancreatic cancer) comprising administering to an individual an effective amount of a composition comprising nanoparticles that comprise a taxane and an albumin and another agent.

First claim

What is claimed is:

1. A method of treating pancreatic cancer in an individual in need thereof, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising paclitaxel coated with an albumin, wherein the nanoparticles in the composition have an average diameter of no greater than about 200 nm, wherein the individual has progressed on a gemcitabine-based therapy, wherein the gemcitabine-based therapy has stopped for at least 6 months when initiating administration of the effective amount of the nanoparticle composition, and wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1 or less.

2. A method of treating resistant or recurrent pancreatic cancer in an individual in need thereof, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising paclitaxel coated with an albumin, wherein the nanoparticles in the composition have an average diameter of no greater than about 200 nm, wherein the individual has progressed on a gemcitabine-based therapy, wherein the gemcitabine-based therapy has stopped for at least 6 months when initiating administration of the effective amount of the nanoparticle composition, and wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1 or less.

3. A method of treating refractory pancreatic cancer in an individual in need thereof, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising paclitaxel coated with an albumin, wherein the nanoparticles in the composition have an average diameter of no greater than about 200 nm, wherein the individual has progressed on a gemcitabine-based therapy, wherein the gemcitabine-based therapy has stopped for at least 6 months when initiating administration of the effective amount of the nanoparticle composition, and wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1 or less.

4. The method of claim 2 , wherein the progression is within less than about 12 months.

5. The method of claim 2 , further comprising administering to the individual an effective amount of another agent.

6. The method of claim 5 , wherein the other agent is selected from the group consisting of 5-fluorouracil, erlotinib, gefitinib, marimastat, irinotecan, tipifarnib, pemetrexed, exatecan, capecitabine, raltitrexed, cetuximab, bevacizumab, bortezomib, rapamycin, vandetanib, and gemcitabine.

7. The method of claim 2 , wherein the pancreatic cancer is exocrine pancreatic cancer or endocrine pancreatic cancer.

8. The method of claim 7 , wherein the exocrine pancreatic cancer is pancreatic ductal carcinoma.

9. The method of claim 2 , wherein the individual is human.

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

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

12. The method of claim 1 , wherein the dose of paclitaxel in the nanoparticle composition is about 50 mg/m 2 to about 300 mg/m 2 .

13. The method of claim 1 , wherein the dose of paclitaxel in the nanoparticle composition is about 260 mg/m 2 .

14. The method of claim 2 , wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1.

15. The method of claim 2 , wherein the albumin is human albumin.

16. The method of claim 2 , wherein the dose of paclitaxel in the nanoparticle composition is about 50 mg/m 2 to about 300 mg/m 2 .

17. The method of claim 2 , wherein the dose of paclitaxel in the nanoparticle composition is about 260 mg/m 2 .

18. The method of claim 3 , wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1.

19. The method of claim 3 , wherein the albumin is human albumin.

20. The method of claim 3 , wherein the dose of paclitaxel in the nanoparticle composition is about 50 mg/m 2 to about 300 mg/m 2 .

21. The method of claim 3 , wherein the dose of paclitaxel in the nanoparticle composition is about 260 mg/m 2 .

22. The method of claim 1 , wherein the progression is within less than about 12 months.

23. The method of claim 1 , further comprising administering to the individual an effective amount of another agent.

24. The method of claim 3 , further comprising administering to the individual an effective amount of another agent.

25. The method of claim 6 , wherein the other agent is gemcitabine.

26. The method of claim 23 , wherein the other agent is gemcitabine.

27. The method of claim 24 , wherein the other agent is gemcitabine.

28. The method of claim 25 , wherein the nanoparticle composition and gemcitabine are administered sequentially to the individual.

29. The method of claim 25 , wherein the nanoparticle composition and gemcitabine are both administered weekly to the individual.

30. The method of claim 25 , wherein the method comprises administering about 50 mg/m 2 to about 250 mg/m 2 paclitaxel in a nanoparticle composition to the individual.

31. The method of claim 25 , wherein the method comprises administering about 100 mg/m 2 to about 150 mg/m 2 paclitaxel in a nanoparticle composition to the individual.

32. The method of claim 31 , wherein the nanoparticle composition and gemcitabine are both administered weekly to the individual.

33. The method of claim 25 , wherein the nanoparticle composition is sterile filterable.

34. The method of claim 25 , wherein the pancreatic cancer is metastatic pancreatic cancer.

35. The method of claim 26 , wherein the nanoparticle composition and gemcitabine are administered sequentially to the individual.

36. The method of claim 26 , wherein the nanoparticle composition and gemcitabine are both administered weekly to the individual.

37. The method of claim 26 , wherein the method comprises administering about 50 mg/m 2 to about 250 mg/m 2 paclitaxel in a nanoparticle composition to the individual.

38. The method of claim 26 , wherein the method comprises administering about 100 mg/m 2 to about 150 mg/m 2 paclitaxel in a nanoparticle composition to the individual.

39. The method of claim 38 , wherein the nanoparticle composition and gemcitabine are both administered weekly to the individual.

40. The method of claim 26 , wherein the nanoparticle composition is sterile filterable.

41. The method of claim 26 , wherein the pancreatic cancer is metastatic pancreatic cancer.

42. The method of claim 27 , wherein the nanoparticle composition and gemcitabine are administered sequentially to the individual.

43. The method of claim 27 , wherein the nanoparticle composition and gemcitabine are both administered weekly to the individual.

44. The method of claim 27 , wherein the method comprises administering about 50 mg/m 2 to about 250 mg/m 2 paclitaxel in a nanoparticle composition to the individual.

45. The method of claim 27 , wherein the method comprises administering about 100 mg/m 2 to about 150 mg/m 2 paclitaxel in a nanopar

Assignees

• Abraxis Bioscience Llc

Inventors

• Desai Neil P
• Soon-Shiong Patrick

Classifications

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P35/00

  Antineoplastic agents · CPC title

• A61P35/04

  specific for metastasis · CPC title

• A61P1/18

  for pancreatic disorders, e.g. pancreatic enzymes · CPC title

• A61K31/16

  Amides, e.g. hydroxamic acids · CPC title