Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments cetuximab, cisplatin, tdt-mediated dutp nick end labeling assay, 3'-deoxy-3'-[18f]fluorothymidine, immunohistochemistry staining method, laboratory biomarker analysis, fludeoxyglucose f 18, radiation therapy
Phase phase 0
Target EGFR
Sponsor Mayo Clinic
Collaborator National Cancer Institute (NCI)
Start date September 2008
End date August 2011
Trial size 30 participants
Trial identifier NCT00757549, 08-002166, MC057M, NCI-2009-01193, P30CA015083

Summary

RATIONALE: Diagnostic procedures, such as 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fludeoxyglucose F 18 (FDG) PET scans, may help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This pilot trial is studying FLT and FDG PET scans to see how well they evaluate response to cetuximab, cisplatin, and radiation therapy in patients with advanced cancer of the oropharynx, larynx, or hypopharynx.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose diagnostic

Primary Outcomes

Measure
Percent change in the standard uptake value levels calculated for the identified volumes of interest for FLT and FDG PET scans from baseline to after 2 weeks of cetuximab therapy and from baseline to after 20-30 Gy of radiotherapy
time frame:

Secondary Outcomes

Measure
Quantified change values (after cetuximab therapy and after 20-30 Gy of radiotherapy) for the FLT and FDG PET scan-based topographic profiles created using the ImQuant software package
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, larynx, or hypopharynx - Advanced disease - Requires chemoradiotherapy PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - Life expectancy ≥ 16 weeks - Weight loss ≤ 10% within the past 3 months - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - ANC ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Total bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST ≤ 3 times ULN - Hemoglobin ≥ 8 g/dL - Creatinine clearance ≥ 40 mL/min - No peripheral neuropathy ≥ grade 2 - No NYHA class III-IV heart disease - No uncontrolled infection - No poorly controlled diabetes that would limit the ability to obtain reliable fludeoxyglucose F 18 PET scan results - No other severe underlying disease that, in the judgment of the investigator, would preclude study participation PRIOR CONCURRENT THERAPY: - More than 2 weeks since prior major surgery and recovered - No prior radiotherapy to the planned treatment field - No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

Additional Information

Official title Comparison of FLT and FDG PET in the Evaluation of Response to Cetuximab, Cisplatin and Radiation Therapy in Advanced Head and Neck Malignancies or Response to Standard Chemo-radiotherapy in Esophageal Malignancies
Description OBJECTIVES: Primary - To assess whether 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fludeoxyglucose F 18 (FDG) PET scans can be used to identify patients with advanced squamous cell carcinoma of the oropharynx, larynx, or hypopharynx who have a biochemical response after 2 weeks of induction therapy with cetuximab. - To assess whether FLT and FDG PET imaging-based response after 20-30 Gy of radiotherapy is predictive of disease control at 6 months after completion of therapy. Secondary - To assess whether FLT and FDG PET imaging-based response after cetuximab therapy and/or 20-30 Gy of radiotherapy is predictive of pathologic complete response in these patients. - To assess whether FLT and FDG PET imaging-based response after cetuximab therapy and/or 20-30 Gy of radiotherapy is predictive of disease-free survival at 2 years in these patients. - To correlate suppression of FLT uptake after cetuximab therapy with thymidine kinase 1 activity and/or expression, proliferation, microvessel density, apoptosis, and signaling pathway analyses. - To correlate suppression of FDG uptake after cetuximab therapy with expression of hexokinases, glucose transporter proliferation, microvessel density, apoptosis, and signaling pathway analyses. - To test and refine the ability of a novel commercial software package to quantify treatment-induced structural and functional/molecular volumetric and sub-volumetric change. - To develop a working method for expressing change and predicting outcome. OUTLINE: Patients receive cetuximab IV on days 1 and 8 of course 1. Beginning in course 2 and all subsequent courses, patients receive cetuximab IV and cisplatin IV over 2 hours on day 1 and undergo radiotherapy once daily 5 days a week for 7 weeks. Treatment repeats every 7 days for a total of 8 courses in the absence of disease progression or unacceptable toxicity. Patients undergo 3'-deoxy-3'-[18F] fluorothymidine and fludeoxyglucose F 18 (FDG) PET scans at baseline, after the second dose of cetuximab, after 20-30 Gy of radiotherapy, and then at 6 weeks and 6 months after completion of radiotherapy. Patients undergo tumor tissue biopsies at baseline and after the first dose of cetuximab for correlative laboratory studies. Samples are analyzed for proliferation (Ki-67 labeling index), microvessel density (CD-31 staining), apoptosis (TUNEL assay and caspase-3 by IHC) signaling pathway (expression of EGFR, AKT, and MAPK by IHC), molecules affecting FDG uptake (expression of GLUT1, GLUT3, and hexokinase by IHC), and thymidine kinase 1 activity or expression. After completion of study treatment, patients are followed every 3 months for up to 5 years.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Mayo Clinic.