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

The Washington University

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Squamous Cell

Treatments: Procedure: FDG-PET/CT; Drug: Cetuximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00671437

08-0285 / 201107108

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Arm 1

Experimental group

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

Treatment:

Procedure: FDG-PET/CT

Drug: Cetuximab