Combination of epothilone analogs and chemotherapeutic agents for the treatment of prolilferative diseases

• US 7,312,237 B2
• Filed: 03/05/2002
• Issued: 12/25/2007
• Est. Priority Date: 03/14/2001
• Status: Active Grant

• Current Assignee: R-pharm us operating llc
• Original Assignee: Bristol-Myers Squibb Company
• Inventors: Lee, Francis Y. F.
• Primary Examiner(s): Padmanabhan; Sreeni
• Assistant Examiner(s): CHONG, YONG SOO
• Application Number:
  US10/091,061
• Publication Number:
  US 20030073677A1
• Time in Patent Office: 2,121 Days
• Field of Search: 514/365, 514/183, 514/450, 514/885, 514/221, 514/219, 514/210.02, 514/291, 514/203, 514/461, 514/469, 514/366, 514/475
• US Class Current: 514/365
• 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 31/33 Heterocyclic compounds
• CPC Class Codes: A61K 31/335 having oxygen as the only ring hetero atom, e.g. fungichromin
• CPC Class Codes: A61K 31/365 Lactones
• CPC Class Codes: A61K 31/427 not condensed and containing further heterocyclic rings
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/18 for pancreatic disorders, e.g. pancreatic enzymes
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/00 Drugs for disorders of the urinary system
• CPC Class Codes: A61P 13/08 of the prostate
• CPC Class Codes: A61P 13/10 of the bladder
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/02 specific for leukemia
• CPC Class Codes: A61P 35/04 specific for metastasis
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/38 of the suprarenal hormones
• CPC Class Codes: A61P 5/44 Glucocorticosteroids; Drugs increasing or potentiating the activity of glucocorticosteroids
• CPC Class Codes: A61P 5/46 for decreasing, blocking or antagonising the activity of glucocorticosteroids

Abstract

Compositions and methods are disclosed which are useful of the treatment and prevention of proliferative disorders.

Claims

1. A method of treating cancer in a mammal selected from metastatic breast cancer, lung cancer, pancreatic cancer, ovarian cancer, prostate cancer, colon cancer, and/or small cell lung cancer, comprising administering to the mammal a therapeutically-effective combination of (1) a dosage unit of capecitabine and (2) a dosage unit of Compound (1), having the formula,

2. The method of claim 1 wherein the cancer is metastatic breast cancer refractory to taxane treatment.

3. The method of claim 1 wherein the cancer is metastatic breast cancer resistant to taxane treatment.

4. The method of claim 1 wherein the cancer is metastatic breast cancer sensitive to taxane treatment.

5. The method according to claim 1, wherein the capecitabine is administered following the administration of Compound 1.

6. The method according to claim 1, wherein the capecitabine is administered before the administration of Compound 1.

7. The method according to claim 1, wherein the capecitabine is administered substantially simultaneously with the administration of Compound 1.

8. The method according to claim 1, wherein the capecitabine is administered orally and the Compound 1 is administered parenterally.

9. The method according to claim 1, wherein the capecitabine is administered orally and the Compound 1 is administered orally.

10. A method of treating cancer in a mammal selected from metastatic breast cancer, lung cancer, pancreatic cancer, ovarian cancer, prostate cancer, colon cancer, and/or small cell lung cancer, comprising administering to the mammal a synergistically-effective combination of capecitabine and Compound (1), having the formula,

11. The method of claim 10, wherein the cancer is metastatic breast cancer.

12. The method of claim 10 wherein the cancer is refractory to taxane treatment.

13. The method of claim 10 wherein the cancer is resistant to taxane treatment.

14. The method of claim 10 wherein the cancer is sensitive to taxane treatment.