Phase 2
Completed N=42
Determine Tumor Response Using Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) Before and After Cetuximab in Patients With Head and Neck Cancer
Carcinoma, Squamous Cell
Source: ClinicalTrials.gov NCT00671437 ↗
Enrolled (actual)
42
Serious AEs
16.7%
Results posted
Aug 2015
Primary outcomePrimary: Metabolic Response of Target Lesions Assessed as the Change in Standardized Uptake Values (SUV) Max on FDG-PET/CT — -21 percentage of change
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 the FDG-PET/CT scans predict response to treatment and survival.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Metabolic Response of Target Lesions Assessed as the Change in Standardized Uptake Values (SUV) Max on FDG-PET/CT |
-21 | — |
| PRIMARY SUVmax 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. |
9.3; 7.3 | — |
| SECONDARY Overall Tumor Metabolic Response to Eight Weeks of Scheduled Weekly Doses of Cetuximab as Assessed by FDG-PET/CT |
15; 12 | — |
| SECONDARY Overall Anatomic Response to Eight Weeks of Scheduled Weekly Doses of Cetuximab as Assessed by CT Scan |
20; 7 | — |
| SECONDARY Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination |
22; 5 | — |
| SECONDARY Overall Best Anatomic Tumor Response Rate to Cetuximab Given Until Disease Progression as Assessed by RECIST Criteria Using CT & Clinical Examination |
1; 20; 7 | — |
| SECONDARY Correlate the Overall Tumor Metabolic Response and Overall Anatomic Tumor Response and Clinical Examination Obtained at Baseline and After Eight Weeks of Treatment With Cetuximab to Time to Progression (TTP) With Cetuximab Therapy |
166; 105; 53 | — |
| SECONDARY Correlate the Overall Tumor Metabolic Response and Overall Anatomic Tumor Response and Clinical Examination Obtained at Baseline and After Eight Weeks of Treatment With Cetuximab to Overall Survival With Cetuximab Therapy |
— | — |
| SECONDARY Determine the Overall Disease Control Rate by RECIST Criteria as Assessed by CT and Clinical Examination and to Determine the TTP and the OS With Cetuximab Therapy |
— | — |
| SECONDARY Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck |
5; 1; 9; 8; 1; 15 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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) 200 at time of PET scanning may need to reschedule to another day after consulting with appropriate physicians.)
Data sourced from ClinicalTrials.gov (NCT00671437). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.