MedTrace Logo

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

NCT01790516 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2014-10-02

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Head and Neck Squamous Cell Cancer

Interventions

DRUG

Cisplatin

Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy

DRUG

cetuximab

Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation.

RADIATION

Radiation

daily radiation for 7 weeks

Sponsors & Collaborators

  • Georgetown University

    lead OTHER

Principal Investigators

  • John F Deeken, MD · Georgetown University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-03-31
Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01790516 on ClinicalTrials.gov