Phase 2 Study to Evaluate the Pharmacokinetics and Drug-Drug Interaction of Cetuximab and Carboplatin in Patients with Recurrent or Metastatic Carcinoma of the Head and Neck
The purpose of this study is to find out what effects, good and/or bad, cetuximab (study drug) has in combination with carboplatin and 5-fluorouracil (5-FU) in participants with recurrent or metastatic head and neck cancer. We would like to understand how the body absorbs, processes and gets rid of the study drug when taken with carboplatin, known as pharmacokinetic (PK) analysis. We also want to see if any drug interactions occur between the study drug and carboplatin.
Recurrent or metastatic cancer of the head and neck.
Adults 18 years of age or older diagnosed with recurrent or metastatic head and neck cancer.
Adequate blood and organ function, determined by screening blood tests.
Patients may be excluded if they:
-have symptomatic brain tumors
-are receiving other investigational drugs or other anti-cancer therapies
-are receiving therapy with immunosuppresive drugs
Additional eligibility criteria apply. Please contact the study team for details.
18 - 100
Healthy Volunteers Needed
Duration of Participation
Treatment is planned for 20 weeks, with the opportunity to continue as long as the cancer is responding to treatment. Patients will be followed after treatment for life.
Senior Research Assistant
Eli Lilly and Company