Head and Neck Cancer Clinical Trial
Official title:
A Phase I Trial of Cetuximab (C225) and Pemetrexed With Concurrent 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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05808920 -
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03997643 -
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04700475 -
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
|
N/A | |
Withdrawn |
NCT04058145 -
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT02572869 -
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
|
||
Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05073809 -
Photoacoustic Imaging of Head and Neck Tumours
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03651570 -
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study
|
N/A | |
Recruiting |
NCT04930432 -
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
Recruiting |
NCT05915572 -
Mulligan Technique on Shoulder Dysfunction
|
N/A | |
Completed |
NCT05897983 -
Tens and Rocabado Exercises on TMJ Dysfunction
|
N/A | |
Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
Withdrawn |
NCT05263648 -
Virtual Reality Software to Reduce Stress in Cancer Patients
|
N/A | |
Withdrawn |
NCT03238638 -
A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
|
Phase 2 |