Cetuximab and Radiation Therapy for Surgically Resectable Esophageal and Gastroesophageal (GE) Junction Carcinomas

Completed · Phase 2

Conditions studied: Esophageal Cancer

In brief

The interaction of epidermal growth factor receptor (EGFR) inhibitory agents such as cetuximab combined with radiation shows promising results. EGFR inhibitory agents also enhance radiation-induced apoptosis and inhibit radiation induced damage repair. These interactions may represent the principle effects that contribute to the synergy between EGFR and radiation. This trial will investigate the feasibility and activity of this combination in patients with surgically resectable disease.

Key facts

Study ID

NCT00319735

Run by

Nasser Hanna, M.D.

People needed

41

Starts

2006-04-01

Expected to finish

2009-01-01

Last updated by the study team

2016-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathological diagnosis of either squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction.
• Clinical stage IIA, IIB or III without metastatic disease
• Patients must have documented EGFR status or have tumor tissue available for assessment of EGFR status by IHC
• Patients must be surgical candidates as determined by surgical consult.
• Patients must agree to surgery.
• ECOG performance status 0 or 2
• Absolute neutrophil count (ANC) > 1,000 mm3
• Platelet count > 75,000 mm3· Hemoglobin > 10g/dL
• Bilirubin < 2.5 X upper limit of normal
• AST (SGOT) or ALT (SGPT) < 5.0 ´ upper limit of normal
• Creatinine < 2.0 X upper limit of normal

You may not qualify if…

• No history of or current brain metastasis.
• No significant history of uncontrolled cardiac disease; i.e. uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
• No history of interstitial pneumonitis or pulmonary fibrosis, or suspicion of interstitial pneumonitis or pulmonary fibrosis on imaging.
• No concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
• No prior use of radiation or chemotherapy for cancer of the esophagus or GE junction
• No prior therapy that specifically and directly targets the EGFR pathway (such as kinase inhibitors and antibodies directed against the HER family receptors).
• No prior severe infusion reaction to a monoclonal antibody.
• No major surgery within 28 days prior to being registered for protocol therapy.
• No clinically significant infections as judged by the treating investigator.
• No acute hepatitis or known HIV.
• No other active malignancies.
• Negative pregnancy test.
• No female patients currently breastfeeding.

Where it is running

• Medical & Surgical Specialists, LLC — Galesburg, Illinois, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• Community Regional Cancer Center — Indianapolis, Indiana, United States
• AP&S Clinic — Terre Haute, Indiana, United States
• Siteman Cancer Center — St Louis, Missouri, United States
• Texas Oncology, PA — Dallas, Texas, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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