Use of Pharmacogenetics to Select Erbitux or Cisplatin to Treat Head and Neck Cancer

Stopped early · Not applicable

Conditions studied: Head and Neck Squamous Cell Cancer

In brief

This study is for patients with newly diagnosed head and neck cancer that cannot be removed by surgery. The purpose of this study is to determine the feasibility of using genetic variations in patients to select the right drug to treat head and neck cancer. Cisplatin and cetuximab (Erbitux)are both approved by the FDA to treat head and neck cancer in combination with radiation therapy. In this study the investigators will test whether genetic differences between patients can be used to pick which of these two drugs a patient should receive. All patients will have a blood sample drawn that will be tested for genetic differences. If patients have genetic differences that correlate with a better outcome from cisplatin they will receive cisplatin with radiation. If patients have genetic differences that do not correlate with a better outcome from cisplatin they will receive cetuximab with their radiation therapy.

Key facts

Study ID: NCT01790516
Run by: Georgetown University
People needed: 2
Starts: 2012-05-01
Expected to finish: 2013-06-01
Last updated by the study team: 2014-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Biopsy proven squamous cell carcinoma of the head and neck, including the oral cavity, oropharynx, hypopharynx, or larynx, but not including primary tumors of the nasopharynx, sinuses, or salivary glands.
Locally advanced, Stage III to IVB disease, and a candidate for primary therapy using chemotherapy and radiation therapy with curative intent.
Patients with a diagnosis of 'unknown primary' will be eligible if chemoradiotherapy is the primary modality of treatment
No previous chemotherapy, radiation, or surgery for their diagnosis of head and neck cancer
Eastern Cooperative Oncology Group performance status </= 1
Women of child-bearing potential must have a negative pregnancy test within 30 hours before initiation of study drug dosing. Female subjects of reproductive potential must agree to avoid pregnancy throughout the study and for up to 3 months following discontinuation of study drug. Male subjects must agree to avoid conceiving a child throughout the study and for up to 3 months following discontinuation of study drug;
Hemoglobin >/= 8.0 gm/dL
Absolute neutrophil count >/= 1500
Platelet count >/= 100,000
Glomerular Filtration Rate > 50 mL/min calculated by the Cockcroft-Gault equation
Total bilirubin </= 2.0 times the upper limit of normal unless the patient has Gilbert's syndrome
Aspartate aminotransferase and Alanine Aminotransferase </= 2.5 times the upper limit of normal
No other current malignancy, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular in situ of the breast. Patients with other malignancies are eligible if they have been continuously disease-free for >/= 3 years prior to screening for this protocol.
Age of 18 or older
Ability and willingness to give informed consent
Subjects must in the opinion of the Investigator be capable of complying with this protocol.

You may not qualify if…

Acute treatment for an infection or other serious medical illness within 14 days prior to study entry
Major surgery within 3 weeks prior to study entry
Known hypersensitivity to cisplatin or cetuximab
Patients who have any severe or uncontrolled medical conditions or other conditions that could affect their participation in this study, including: unstable angina, serious uncontrolled cardiac arrhythmia, active acute or uncontrolled infectious disorder, or myocardial infarction </= 6 months prior to study entry.
Female patients who are pregnant or breast feeding, or adults who are of reproductive potential and are unwilling to refrain from conceiving a child during study treatment.
Patients unwilling to comply with the protocol, or provide informed consent
Psychiatric illness that would limit compliance with study requirements

Where it is running

Georgetown Lombardi Comprhensive Cancer Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.