OHSU

IRB #

IRB00009925

Title

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

Principal Investigator

Kathleen Kemmer

Study Purpose

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.

Medical Condition(s)

Recurrent or metastatic cancer of the head and neck.

Eligibility Criteria

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.

Age Range

18 - 100

Healthy Volunteers Needed

No

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.

Minors Included

No

Contact

Will Stott
Senior Research Assistant
Phone: 503-418-9235
Email: stottw@ohsu.edu

Sponsor

Eli Lilly and Company

Recruitment End

12/30/2015

Compensation Provided

No


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