Trial of Cetuximab and Pemetrexed With Radiation in Head and Neck Cancer
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.
Head and Neck Cancer
Procedure: radiation therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of Cetuximab (C225) and Pemetrexed With Concurrent Radiation in Head and Neck Cancer|
- To evaluate the maximum tolerated doses and dose-limiting toxicities of Pemetrexed and Cetuximab when given concurrently with radiation in poor prognosis subjects with head and neck cancer. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
- To evaluate the objective response rate post chemoradiotherapy (in subjects with measurable disease), time to progression, and overall survival with the above therapy. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- To collect tumor tissue from pretreatment biopsies for future biomarker studies and to collect pre- and post-therapy blood samples for future studies, that may include analysis of DNA and RNA extracted from these samples. [ Time Frame: indefinite ] [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Study Completion Date:||January 2009|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
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 body's 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.
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Julie E Bauman, MD||University of Pittsburgh|