Clinical trial · Interventional
Determine Tumor Response Using Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) Before and After Cetuximab in Patients With Head and Neck Cancer
Determination of Tumor SUV by FDG-PET/CT Before and After Cetuximab in Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT00671437CI-TRIAL-00026436SCCHNcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Squamous Cell | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| FDG-PET/CT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1) Cetuximab 400 mg/m2 intravenously (IV) over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50. Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion) Cetuximab 250 mg/m2 IV over 1 hour on Day 57 Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease
- interventionNames
- Procedure: FDG-PET/CT
- Drug: Cetuximab
Primary outcomes (2)
- measure
- Metabolic Response of Target Lesions Assessed as the Change in Standardized Uptake Values (SUV) Max on FDG-PET/CT
- timeFrame
- Baseline and after 8 weeks of treatment
- description
- FDG-PET/CT images were evaluated qualitatively as well as quantitatively by one of two experienced nuclear radiologists. For quantitative analysis, SUVmax within each of the metastatic tumor sites was determined within a volume of interest around the tumor using a Siemens eSoft workstation. Up to a maximum of three target lesions(\>= 1.5 cm on the baseline CT) were identified as target lesions on the baseline FDG-PET. When multiple lesions were present, those having the greatest FDG uptake on the baseline FDG-PET were selected as target lesions. Lesions containing areas of necrosis were avoided. Other metabolically active lesions and lesions that were \<1.5 cm on CT were considered non-target lesions. When more than one target lesion was identified, the average percentage change in SUVmax was used to determine metabolic response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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) \<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.)
References
Publications (23)
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- BACKGROUNDAng KK, Berkey BA, Tu X, Zhang HZ, Katz R, Hammond EH, Fu KK, Milas L. Impact of epidermal growth factor receptor expression on survival and pattern of relapse in patients with advanced head and neck carcinoma. Cancer Res. 2002 Dec 15;62(24):7350-6. PMID 12499279
- BACKGROUNDHuang S, Armstrong EA, Benavente S, Chinnaiyan P, Harari PM. Dual-agent molecular targeting of the epidermal growth factor receptor (EGFR): combining anti-EGFR antibody with tyrosine kinase inhibitor. Cancer Res. 2004 Aug 1;64(15):5355-62. doi: 10.1158/0008-5472.CAN-04-0562. PMID 15289342
- BACKGROUNDCohen EE, Rosen F, Stadler WM, Recant W, Stenson K, Huo D, Vokes EE. Phase II trial of ZD1839 in recurrent or metastatic squamous cell carcinoma of the head and neck. J Clin Oncol. 2003 May 15;21(10):1980-7. doi: 10.1200/JCO.2003.10.051. PMID 12743152
- BACKGROUNDBonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. doi: 10.1056/NEJMoa053422.