A Phase II Organ Preservation Trial Using Cetuximab and Radiation Therapy in Advanced Laryngeal Cancer Patients Who Have Responded to One Cycle of Induction Chemotherapy With Taxotere, Cisplatin, 5-Fluorouracil (TPF), and Cetuximab
In this study one cycle of chemotherapy will be administered and then those subjects who
respond well to that cycle will be started on radiation therapy along with chemotherapy and
those that don't respond well to the initial cycle of chemotherapy, will undergo a total
laryngectomy (surgery to remove the voice box) followed by radiation therapy. The initial
cycle of chemotherapy consists of the drugs Taxotere, Cisplatin, and 5-Fluorouracil (this
combination is known as TPF). Then on Day 20 of the study, the subjects will be administered
another chemotherapy agent called cetuximab (a.k.a. C-225). It will then be determined if
the patient's response to the chemotherapy was favorable by examining the patient's tumor
with an endoscopy. If the response is determined to be good, then the patient will continue
with a chemotherapy regimen with the addition of radiation therapy combination. If the
patient's response to the chemotherapy is determined to be less than favorable, then the
patient will be advised to undergo salvage surgery (a.k.a. laryngectomy) to remove their
voice box and then undergo radiation therapy treatment. Additionally, tumor tissue samples
and blood will be studied to see if there are special molecular markers that help predict
when a tumor will respond to chemotherapy and radiation treatment.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine rates of histologic complete response (CR) as compared to historical controls.
Francis P. Worden, M.D.
University of Michigan
United States: Institutional Review Board
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|