Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291707
Status:
COMPLETED
Last Update Posted:
2013-05-06
First Post:
2006-02-10
Brief Title:
Trial of Cetuximab and Pemetrexed With Radiation in Head and Neck Cancer
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Phase I Trial of Cetuximab C225 and Pemetrexed With Concurrent Radiation in Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this Phase I study is to determine the safety and effectiveness of two chemotherapies drugs Cetuximab and Pemetrexed Alimta when given in combination with radiation therapy
Detailed Description:
The purpose of this Phase I study is to determine the safety and effectiveness of two chemotherapies drugs Cetuximab and Pemetrexed Alimta when given in combination with radiation therapy Currently Pemetrexed is approved by the Food and Drug Administration FDA for two other types of cancer mesothelioma and lung cancer but it is considered investigational and is not approved by the FDA for head and neck cancer Cetuximab is approved by the FDA for the treatment of colorectal cancer however it is not yet approved for head and neck cancer
Pemetrexed is a drug that kills tumor cells by stopping cells from functioning normally It has been studied in thousands of subjects and has been shown to be effective at killing tumor cells in many cancers including head and neck cancer In preclinical studies Pemetrexed showed such promising activity against a wide range of tumor types including those mentioned above as well as breast colon and bladder cancers
Cetuximab also known as C225 and Erbitux can increase the effectiveness of our standard treatment with chemotherapy and radiation Cetuximab is a type of drug known as a monoclonal antibody Monoclonal antibodies are used to try to destroy some types of cancer cells while causing little harm to normal cells They are designed to recognize specific molecules that are on the surface of particular cancer cells The monoclonal antibody recognizes the protein and locks onto it This may trigger the bodys immune system to attack the cancer cells and can sometimes make the cells destroy themselves Cetuximab targets the epidermal growth factor receptor EGFR an important molecule for the growth of cancer cells The use of radiation therapy and Cetuximab has also been studied with good results We will find what effects good and bad Cetuximab has on you and your head and neck cancer
Both Cetuximab and Pemetrexed have been studied intensively to determine their effectiveness
In this study we will find what effects good and bad Cetuximab and Pemetrexed with radiation have on you and on your head and neck cancer We will find out if the combination of Cetuximab Pemetrexed and radiation has better results than what we ordinarily expect with radiation and chemotherapy We will also find out if the side effects are worse than those we usually see In addition we will test both blood and tumor tissue and determine what effects Cetuximab has on these specimens Finally we will look for markers or cancer identifiers in your tumor cells and blood that may help to predict what the best treatment is for head and neck cancer patients in the future
Pemetrexed is a drug that kills tumor cells by stopping cells from functioning normally It has been studied in thousands of subjects and has been shown to be effective at killing tumor cells in many cancers including head and neck cancer In preclinical studies Pemetrexed showed such promising activity against a wide range of tumor types including those mentioned above as well as breast colon and bladder cancers
Cetuximab also known as C225 and Erbitux can increase the effectiveness of our standard treatment with chemotherapy and radiation Cetuximab is a type of drug known as a monoclonal antibody Monoclonal antibodies are used to try to destroy some types of cancer cells while causing little harm to normal cells They are designed to recognize specific molecules that are on the surface of particular cancer cells The monoclonal antibody recognizes the protein and locks onto it This may trigger the bodys immune system to attack the cancer cells and can sometimes make the cells destroy themselves Cetuximab targets the epidermal growth factor receptor EGFR an important molecule for the growth of cancer cells The use of radiation therapy and Cetuximab has also been studied with good results We will find what effects good and bad Cetuximab has on you and your head and neck cancer
Both Cetuximab and Pemetrexed have been studied intensively to determine their effectiveness
In this study we will find what effects good and bad Cetuximab and Pemetrexed with radiation have on you and on your head and neck cancer We will find out if the combination of Cetuximab Pemetrexed and radiation has better results than what we ordinarily expect with radiation and chemotherapy We will also find out if the side effects are worse than those we usually see In addition we will test both blood and tumor tissue and determine what effects Cetuximab has on these specimens Finally we will look for markers or cancer identifiers in your tumor cells and blood that may help to predict what the best treatment is for head and neck cancer patients in the future
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None