US2013149299A1PendingUtilityA1

Dosages for treatment with anti-egfr antibodies

59
Individually held — no corporate assignee on recordPriority: Aug 27, 1999Filed: Mar 8, 2012Published: Jun 13, 2013
Est. expiryAug 27, 2019(expired)· nominal 20-yr term from priority
Inventors:Sharon A. BaughmanSteven Shak
A61P 9/00A61P 35/04A61P 43/00A61P 35/00A61P 35/02A61P 15/00C07K 16/30A61K 39/39558A61K 2039/505A61K 2039/545C07K 16/32A61K 39/395A61K 2039/54A61K 31/337A61K 38/00A61K 45/06
59
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Claims

Abstract

The present invention concerns dosages for treatment of human cancer patients with an anti-Epidermal Growth Factor Receptor (EGFR) antibody.

Claims

exact text as granted — not AI-modified
1 . A method for the treatment of cancer in a human patient, comprising administering an effective amount of an anti-epidermal growth factor receptor (EGFR) antibody to the human patient, the method comprising: administering to the patient an initial dose of at least approximately 5 mg/kg of the anti-EGFR antibody; and
 administering to the patient a plurality of subsequent doses of the antibody in an amount that is approximately the same or less than the initial dose.   
     
     
         2 . The method of  claim 1 , wherein the initial dose is at least approximately 6 mg/kg. 
     
     
         3 . The method of  claim 2 , wherein the initial dose is at least approximately 8 mg/kg. 
     
     
         4 . The method of  claim 3 , wherein the initial dose is at least approximately 12 mg/kg. 
     
     
         5 . The method of  claim 1 , wherein the subsequent doses are separated from each other in time by at least one week. 
     
     
         6 . The method of  claim 5 , wherein the subsequent doses are separated in time from each other by at least two weeks. 
     
     
         7 . The method of  claim 6 , wherein the subsequent doses are separated in time from each other by at least three weeks. 
     
     
         8 . The method of  claim 1 , wherein the initial dose is administered by intravenous injection, and wherein at least one subsequent dose is administered by subcutaneous injection. 
     
     
         9 . The method of  claim 1 , wherein said cancer is selected from the group consisting of breast cancer, leukemia, squamous cell cancer, small-cell lung cancer, non-small cell lung cancer, gastrointestinal cancer, pancreatic cancer, glioblastoma, cervical cancer, ovarian cancer, liver cancer, bladder cancer, hepatoma, colon cancer, colorectal cancer, endometrial carcinoma, salivary gland carcinoma, kidney cancer, liver cancer, prostate cancer, vulval cancer, thyroid cancer, hepatic carcinoma and various types of head and neck cancer. 
     
     
         10 . The method of  claim 1 , wherein the anti-EGFR antibody comprises chimerized 225 (C225). 
     
     
         11 . The method of  claim 1 , wherein the method further comprises administering an effective amount of a chemotherapeutic agent. 
     
     
         12 . The method of  claim 1 , wherein efficacy is measured by determining the time to disease progression or the response rate. 
     
     
         13 . A method for the treatment of cancer in a human patient comprising administering to the patient a first dose of an anti-epidermal growth factor receptor (EGFR) antibody followed by at least one subsequent dose of the antibody, wherein the first dose and subsequent dose are separated from each other in time by at least about two weeks. 
     
     
         14 . The method of  claim 13 , wherein the first dose and subsequent dose are separated from each other in time by at least about three weeks. 
     
     
         15 . The method of  claim 13 , wherein the first dose and subsequent dose are each from about 2 mg/kg to about 16 mg/kg. 
     
     
         16 . The method of  claim 13 , wherein the first dose and subsequent dose are each from about 4 mg/kg to about 12 mg/kg. 
     
     
         17 . The method of  claim 14 , wherein the first dose and subsequent dose are each from about 6 mg/kg to about 12 mg/kg. 
     
     
         18 . The method of  claim 13 , wherein two or more subsequent doses of the antibody are administered to the patient. 
     
     
         19 . The method of  claim 18 , wherein from about two to about ten subsequent doses of the antibody are administered to the patient. 
     
     
         20 . The method of  claim 18 , wherein the two or more subsequent doses are separated from each other in time by at least about two weeks. 
     
     
         21 . The method of  claim 18 , wherein the two or more subsequent doses are separated from each other in time by at least about three weeks. 
     
     
         22 . The method of  claim 18 , wherein the two or more subsequent doses are each from about 2 mg/kg to about 16 mg/kg. 
     
     
         23 . The method of  claim 18 , wherein the two or more subsequent doses are each from about 4 mg/kg to about 12 mg/kg. 
     
     
         24 . The method of  claim 18 , wherein the two or more subsequent doses are each from about 6 mg/kg to about 12 mg/kg. 
     
     
         25 . The method of  claim 13 , wherein the method further comprises administering an effective amount of a chemotherapeutic agent to the patient. 
     
     
         26 . A method for the treatment of cancer in a human patient, comprising administering an effective amount of an anti-epidermal growth factor receptor (EGFR) antibody to the human patient, the method comprising: administering to the patient an initial dose of at least approximately 5 mg/kg of the anti-EGFR antibody; and administering to the patient a plurality of subsequent doses of the antibody in an amount that is approximately the same or less than the initial dose, wherein the subsequent doses are separated in time from each other by at least two weeks. 
     
     
         27 . A method for the treatment of cancer in a human patient comprising administering to the patient a first dose of an anti-epidermal growth factor receptor (EGFR) antibody followed by two or more subsequent doses of the antibody, wherein the subsequent doses are separated in time from each other by at least two weeks.

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