Method of treating prostatic diseases using a combination of vitamin D analogues and other agents

• US 20060003950A1
• Filed: 06/30/2004
• Published: 01/05/2006
• Est. Priority Date: 06/30/2004
• Status: Abandoned Application

• Current Assignee: Bone Care International LLC
• Original Assignee: Bone Care International LLC
• Inventors: Strugnell, Stephen A., Wigington, Don
• Application Number:
  US10/881,183
• Publication Number:
  US 20060003950A1
• Time in Patent Office: Days
• US Class Current: 514/34
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/138 Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377
• CPC Class Codes: A61K 31/255 of sulfoxy acids or sulfur analogues thereof
• CPC Class Codes: A61K 31/282 Platinum compounds
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 31/513 having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
• CPC Class Codes: A61K 31/555 containing heavy metals, e.g. hemin, hematin, melarsoprol
• CPC Class Codes: A61K 31/592 9,10-Secoergostane derivatives, e.g. ergocalciferol, i.e. vitamin D2
• CPC Class Codes: A61K 31/70 Carbohydrates; Sugars; Derivatives thereof sorbitol A61K31/047
• CPC Class Codes: A61K 31/704 attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin digitoxin A61K31/7048
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

The invention provides therapeutic methods for inhibiting, ameliorating or alleviating the hyperproliferative cellular activity of diseases of the prostate, e.g., prostatic cancer and prostatic hyperplasia, which includes administering to a patient in need thereof an active vitamin D analogue and another anticancer agent. Cell differentiation is promoted, induced or enhanced without causing to the patient dose-limiting hypercalcemia and hypercalciuria.

Claims

1. A method of synergistically inhibiting the growth of human prostatic neoplastic or hyperplastic cells, comprising contacting the cells with a first composition which comprises 1α

,24-dihydroxyvitamin d₂ and a second composition which comprises carboplatin.

2. The method of claim 1, wherein the first and second compositions are administered to a human cancer patient.

3. The method of claim 2 wherein the first and second compositions are co-administered.

4. The method of claim 2 wherein the first and second compositions are administered in a daily regimen.

5. The method of claim 2 wherein the first and second compositions are administered in a episodic regimen.

6. The method of claim 2 wherein the first composition is administered intravenously.

7. The method of claim 2 wherein the first composition is administered orally.

8. The method of claim 2 wherein the first composition is administered amount in an amount of 0.01 μ

g to 400 μ

g.

9. A pharmaceutical combination for the inhibition of the hyperproliferative activity of human prostatic neoplastic or hyperplastic cells which comprises a therapeutically effective dose of a synergistic combination of a first agent which is 1α

,24-dihydroxyvitamin D₂ and a second agent which is carboplatin.

10. A pharmaceutical combination comprising a first agent which is 1α

,24-dihydroxyvitamin D₂ and a second agent which is carboplatin, wherein the first and second agents have synergistic properties for inhibiting the hyperproliferative activity of human prostatic neoplastic or hyperplastic cells.

11. A method of additively inhibiting the growth of human prostatic neoplastic or hyperplastic cells, comprising contacting the cells with a first composition comprising 1α

,24-dihydroxyvitamin D₂ and a second composition which comprises an agent selected from the group consisting of carboplatin, doxorubicin, chlorambucil, busulfan, cisplatin, paclitaxel, etoposide, 5-flurouracil, and tamofixen.

14. The method of claim 11 wherein the agent is chlorambucil.

15. The method of claim 11 wherein the agent is busulfan.

16. The method of claim 11 wherein the agent is cisplatin.

17. The method of claim 11 wherein the agent is paclitaxel.

18. The method of claim 11 wherein the agent is etoposide.

19. The method of claim 11 wherein the agent is 5-flurouracil.

20. The method of claim 11 wherein the agent is tamofixen.

21. The method of claim 11, wherein the first and second compositions are administered to a human cancer patient.

22. The method of claim 21 wherein the first and compositions agents are co-administered.

23. The method of claim 21 wherein the first and second compositions are administered in a daily regimen.

24. The method of claim 21 wherein the first and second compositions are administered in a episodic regimen.

25. The method of claim 21 wherein the first composition is administered intravenously.

26. The method of claim 21 wherein the first composition is administered orally.

27. The method of claim 21 wherein the first composition is administered amount in an amount of 0.01 μ

g to 400 μ

g.

12. The method of claim 111 wherein the agent is carboplatin.

13. The method of claim 111 wherein the agent is doxorubicin.

28. A pharmaceutical combination for the inhibition of growth of human prostatic neoplastic or hyperplastic cells which comprises a therapeutically effective dose of an additive combination of a first agent which is 1α

,24-dihydroxyvitamin D₂ and a second agent selected from the group consisting of carboplatin, doxorubicin, chlorambucil, busulfan, cisplatin, paclitaxel, etoposide, 5-flurouracil, and tamofixen.

29. A pharmaceutical combination comprising a first agent which is 1α

,24-dihydroxyvitamin D₂ and a second agent which is selected from the group consisting of carboplatin, doxorubicin, chlorambucil, busulfan, cisplatin, paclitaxel, etoposide, 5-flurouracil, and tamofixen, wherein the first and second agents have additive properties for inhibiting the hyperproliferative activity of human prostatic neoplastic or hyperplastic cells.