Status:
COMPLETED
Cetuximab and Radiation Therapy for Surgically Resectable Esophageal and Gastroesophageal (GE) Junction Carcinomas
Lead Sponsor:
Nasser Hanna, M.D.
Collaborating Sponsors:
Bristol-Myers Squibb
Walther Cancer Institute
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ap...
Detailed Description
OUTLINE: This is a multi-center study. * Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) * Cetuximab 250 mg/m2 IV over 60 minutes, day -7. * Cetuximab 250 mg/m2 IV over 60 minutes, day...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00319735
Start Date
April 1 2006
End Date
January 1 2009
Last Update
April 28 2016
Active Locations (7)
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1
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
2
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
3
Community Regional Cancer Center
Indianapolis, Indiana, United States, 46256
4
AP&S Clinic
Terre Haute, Indiana, United States, 47804