BrUOG-EG-203 Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer BMS#CA225091
- Patients are required to have pathologically confirmed adenocarcinoma or squamous
cell carcinoma of the esophagus, gastroesophageal junction, or stomach.
- Patients may have mediastinal, celiac adenopathy, peri-portal and regional gastric
- There must be no evidence of distant organ metastases.
- No prior radiation for gastric or esophageal cancer.
- Patients must be > 18 years of age, and nonpregnant
- Patients must have an ANC > 1,500/ul, platelets > 100,000/ul, creatinine < 2 x upper
limit normal (ULN) and bilirubin < 1.5 x ULN, and AST < 3 x ULN.
- ECOG performance status 0-2.
- Patients must not have significant infection or other coexistent medical condition
that would preclude protocol therapy.
- Female patients, must either be not of child bearing potential or have a negative
pregnancy test within 7 days of starting study treatment. Patients are considered not
of child bearing potential if they are surgically sterile (they have undergone a
hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are
postmenopausal. Pregnant or lactating females are not eligible.
- All patients must sign informed consent
Any of the following criteria will make the patient ineligible to participate in this
- Acute hepatitis or AIDS.
- Active or uncontrolled infection.
- 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.
- Prior therapy which specifically and directly targets the EGFR pathway.
- Prior severe infusion reaction to a monoclonal antibody.
- Any concurrent chemotherapy not indicated in the study protocol or any other