Status:
COMPLETED
Determine Tumor Response Using Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) Before and After Cetuximab in Patients With Head and Neck Cancer
Lead Sponsor:
Washington University School of Medicine
Conditions:
Carcinoma, Squamous Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 th...
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00671437
Start Date
June 1 2008
End Date
August 1 2015
Last Update
March 14 2017
Active Locations (2)
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1
University of Louisville
Louisville, Kentucky, United States
2
Washington University
St Louis, Missouri, United States, 63110