Trial of Cetuximab and Pemetrexed With Radiation in Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00291707|
Recruitment Status : Completed
First Posted : February 14, 2006
Last Update Posted : May 6, 2013
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Cetuximab Drug: Pemetrexed Procedure: radiation therapy||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Cetuximab (C225) and Pemetrexed With Concurrent Radiation in Head and Neck Cancer|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||January 2009|
- Drug: Cetuximab
The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes. The infusion rate of cetuximab must never exceed 5 mL/min.Other Names:
- Drug: Pemetrexed
• Pemetrexed 350-500 mg/m2 IV over 10 minutes (see dose escalation design. Dose will be decreased to 200 mg/m2, if the first dose level of 350 mg/m2 is not tolerable) on days 1 and 22, (and 43 if >6000 cGy to be delivered)Other Name: ALIMTA
- Procedure: radiation therapy
• Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1. Radiation will be given M-F for 6-7 consecutives weeks
- 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 ]
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291707
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Julie E Bauman, MD||University of Pittsburgh|