METHODS FOR TREATING CANCER COMPRISING THE ADMINISTRATION OF A VITAMIN D COMPOUND AND AN ADDITIONAL THERAPEUTIC AGENT, AND COMPOSITIONS CONTAINING THE SAME

• US 20080051375A1
• Filed: 08/24/2007
• Published: 02/28/2008
• Est. Priority Date: 08/25/2006
• Status: Abandoned Application

• Current Assignee: JANSSEN ONCOLOGY, INC. (Johnson & Johnson)
• Original Assignee: JANSSEN ONCOLOGY, INC. (Johnson & Johnson)
• Inventors: Belldegrun, Arie, Auerbach, Alan
• Application Number:
  US11/844,445
• Publication Number:
  US 20080051375A1
• Time in Patent Office: Days
• US Class Current: 514/167
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 31/59 Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

Methods and compositions for treating cancer are described herein. More particularly, the methods for treating cancer comprise administering a vitamin D compound in combination with at least one additional therapeutic agent, such as an anti-cancer agent or a steroid. Furthermore, disclosed are compositions comprising vitamin D compounds and at least one additional therapeutic agent, such as an anti-cancer agent or a steroid, e.g., corticosteroid or more specifically, a glucocorticoid.

Claims

1. A method for the treatment of a prostate cancer or a breast cancer in a mammal comprising administering a therapeutically effective amount of a vitamin D compound and a therapeutically effective amount of at least one additional therapeutic agent to a patient having a prostate cancer or a breast cancer.

2. The method of claim 1, wherein the vitamin D compound comprises seocalcitol.

3. The method of claim 1, wherein the therapeutically effective amount of the vitamin D compound comprises about 0.001 μ

g/day to about 1000 μ

g/day.

4. The method of claim 1, wherein the additional therapeutic agent comprises an anti-neoplastic agent, an alkylating agent, an anti-metabolite agent, an antibiotic agent, a hormonal ablation agent, an androgen ablation agent, an anti-androgen agent, or a steroid.

5. The method of claim 1, wherein the vitamin D compound and the additional therapeutic agent are administered to the mammal in a single composition comprising the vitamin D compound and the additional therapeutic agent.

6. The method of claim 1, wherein the vitamin D compound and the additional therapeutic agent are administered separately to the mammal.

7. The method of claim 1, wherein the vitamin D compound is administered by pulse administration.

8. The method of claim 1, wherein the method further comprises administering an anti-hypercalcemic agent.

9. The method of claim 1, wherein the vitamin D compound comprises seocalcitol and the additional therapeutic agent comprises mitoxantrone, paclitaxel, docetaxel, leuprolide, goserelin, triptorelin, abiraterone acetate, bicalutamide, flutamide, hydrocortisone, prednisone or dexamethasone.

10. The method of claim 9, wherein the therapeutically effective amount of the seocalcitol comprises about 0.1 μ

g/day to about 500 μ

g/day and the therapeutically effective amount of the additional therapeutic agent comprises about 0.1 mg/m² to about 20 mg/m ² of mitoxantrone.

11. The method of claim 9, wherein the therapeutically effective amount of the seocalcitol comprises about 0.1 μ

g/day to about 500 μ

g/day and the therapeutically effective amount of the additional therapeutic agent comprises about 1 mg/m² to about 175 mg/m² of paclitaxel.

12. The method of claim 9, wherein the therapeutically effective amount of the seocalcitol comprises about 0.1 μ

g/day to about 500 μ

g/day and the therapeutically effective amount of the additional therapeutic agent comprises about 1 mg/m² to about 100 mg/m² of docetaxel.

13. The method of claim 9, wherein the therapeutically effective amount of the seocalcitol comprises about 0.1 μ

g/day to about 500 μ

g/day and the therapeutically effective amount of the additional therapeutic agent comprises about 0.01 to about 200 mg of leuprolide over a period of about 3 days to about 12 months.

14. The method of claim 9, wherein the therapeutically effective amount of the seocalcitol comprises about 0.1 μ

g/day to about 500 μ

g/day and the therapeutically effective amount of the additional therapeutic agent comprises about 0.01 mg to about 20 mg of goserelin over a period of about 28 days to about 3 months.

15. The method of claim 9, wherein the therapeutically effective amount of the seocalcitol comprises about 0.1 μ

g/day to about 500 μ

g/day and the therapeutically effective amount of the additional therapeutic agent comprises about 0.01 mg to about 20 mg of triptorelin over a period of about 1 month.

16. The method of claim 9, wherein the therapeutically effective amount of the seocalcitol comprises about 0.1 μ

g/day to about 500 μ

g/day and the therapeutically effective amount of the additional therapeutic agent comprises about 0.4 mg/day to about 10,000 mg/day of abiraterone acetate.

17. The method of claim 9, wherein the therapeutically effective amount of the seocalcitol comprises about 0.1 μ

g/day to about 500 μ

g/day and the therapeutically effective amount of the additional therapeutic agent comprises about 1 mg/day to about 300 mg/day of bicalcutamide.

18. The method of claim 9, wherein the therapeutically effective amount of the seocalcitol comprises about 0.1 μ

g/day to about 500 μ

g/day and the therapeutically effective amount of the additional therapeutic agent comprises about 1 mg/day to about 2000 mg/day flutamide.

19. The method of claim 9, wherein the therapeutically effective amount of the seocalcitol comprises about 0.1 μ

g/day to about 500 μ

g/day and the therapeutically effective amount of the additional therapeutic agent comprises about 10 mg/day to about 250 mg/day of hydrocortisone or prednisone.

20. The method of claim 9, wherein the therapeutically effective amount of the seocalcitol comprises about 0.1 μ

g/day to about 500 μ

g/day and the therapeutically effective amount of the additional therapeutic agent comprises about 0.5 mg/day to about 25 mg/day dexamethasone.

21. A method for treating a patient having refractory prostate cancer or refractory breast cancer who is currently receiving at least one treatment for cancer, the method comprising administering a therapeutically effective amount of a vitamin D compound in addition to the at least one treatment the patient is currently receiving.

22. The method of claim 21, wherein the vitamin D compound comprises seocalcitol.

23. The method of claim 21, wherein the therapeutically effective amount of the vitamin D compound comprises about 0.001 μ

g/day to about 1000 μ

g/day.

24. The method of claim 21, wherein the treatment for cancer comprises the administration of mitoxantrone, paclitaxel, docetaxel, leuprolide, goserelin, triptorelin, abiraterone acetate, bicalutamide, flutamide, hydrocortisone, prednisone or dexamethasone.

25. A pharmaceutical composition for the treatment of a cancer in a mammal comprising a therapeutically effective amount of seocalcitol and a therapeutically effective amount of a steroid, wherein the composition is suitable for oral administration.

26. The composition of claim 25, wherein the composition comprises about 0.1 μ

g to about 500 μ

g of seocalcitol and about 0.25 mg to about 3.5 mg of the steroid.

27. The composition of claim 25, wherein the steroid comprises hydrocortisone, prednisone or dexamethasone.

28. The composition of claim 25, wherein the composition is in the form of a pill, tablet or capsule.