Carcinoma, Squamous Cell Clinical Trial
Official title:
Determination of Tumor SUV by FDG-PET/CT Before and After Cetuximab in Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
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.
Primary Endpoint
To compare the SUV (standardized uptake value) at up to three target tumor sites as assessed
by FDG-PET/CT of eligible patients at baseline and then after eight weeks of treatment with
cetuximab.
Secondary Endpoints
- To determine the overall tumor metabolic response (complete metabolic response, partial
metabolic response, stable metabolic disease or progressive metabolic disease [CMR,
PMR, SMD, or PMD]) to eight weeks of scheduled weekly doses of cetuximab as assessed by
FDG-PET/CT performed at baseline and then after therapy.
- To correlate the overall tumor metabolic response (CMR, PMR, SMD, or PMD) as assessed
by FDG-PET/CT with the anatomic tumor response rate (complete response, partial
response, stable disease or progressive disease [CR, PR, SD, or PD]) by RECIST criteria
as assessed by CT and clinical examination performed after eight weeks of scheduled
weekly doses of cetuximab.
- To correlate the overall tumor metabolic response (CMR, PMR, SMD, or PMD) as assessed
by FDG-PET/CT and to correlate the overall anatomic tumor response (CR, PR, SD, or PD)
by RECIST criteria as assessed by CT and clinical examination obtained at baseline and
after eight weeks of treatment with weekly scheduled doses of cetuximab to TTP (time to
progression) and OS (overall survival) with cetuximab therapy.
- To determine the overall best anatomic tumor response rate (CR, PR, SD, or PD) to
cetuximab given until disease progression as assessed by RECIST criteria using CT and
clinical examination.
- To determine the overall disease control rate (CR, PR, and SD) by RECIST criteria as
assessed by CT and clinical examination and to determine the TTP and the OS with
cetuximab therapy.
- To assess the toxicity profile for standard of care cetuximab given to patients with
metastatic squamous cell carcinoma of the head and neck.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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