Determine Tumor Response Using Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) Before and After Cetuximab in Patients With Head and Neck Cancer

Completed · Phase 2

Conditions studied: Carcinoma, Squamous Cell

In brief

The purpose of this study is to collect data and evaluate how the tumor is broken down in response to standard of care cetuximab treatment by evaluating the FDG-PET/CT scans, toxicity, see how well the FDG-PET/CT scans predict response to treatment and survival.

Key facts

Study ID

NCT00671437

Run by

Washington University School of Medicine

People needed

42

Starts

2008-06-01

Expected to finish

2015-08-01

Last updated by the study team

2017-03-14

Who can join

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

You may qualify if…

• Histologically proven diagnosis of squamous cell carcinoma of the head and neck (SCCHN).
• Have either locally recurrent, unresectable, previously irradiated SCCHN OR metastatic SCCHN, with at least one measurable tumor lesion (by CT scan) and at least one FDG avid (SUV >/= 3, >/= 1.5 cm) tumor lesion (by PET/CT).
• Age greater than 18 yrs.
• ECOG Performance Status of 0-3
• Signed IRB approved Informed Consent.

You may not qualify if…

• Clinical history of severe interstitial lung disease (not COPD)-as defined by prior pulmonary function tests (PFTs) with residual volume, total lung capacity, or corrected diffuse lung capacity for carbon monoxide (DLCO) <30% of predicted. For this study, screening PFT's required only if clinically indicated.
• Prior therapy with an epidermal growth factor receptor (EGFR)-specific monoclonal antibody (MAB) for treatment of metastatic SCCHN. Prior therapy with an EGFR-specific MAB as part of the definitive treatment of non-metastatic SCCHN is acceptable if this occurred more than three months previously. Prior therapy with an EGFR specific TKI will not be an exclusion factor.
• Women of child bearing potential who are current pregnant or breast feeding.
• Prior severe (Grade 4) infusion reaction to cetuximab.
• A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy.
• Chemotherapy, radiation therapy, or investigational agents given with the last 14 days.
• Uncontrolled diabetes mellitus. (Subjects with a fasting blood glucose > 200 at time of PET scanning may need to reschedule to another day after consulting with appropriate physicians.)

Where it is running

• University of Louisville — Louisville, Kentucky, United States
• Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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