Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer

The primary objective of this phase II trial is to estimate the rate of complete pathologic response as determined by surgical resection or post treatment endoscopy (for patients not undergoing resection) for the treatment regimen being tested. With a total accrual of 28 evaluable patients.

Inclusion Criteria:

• 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 lymphadenopathy.
• 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

Exclusion Criteria:

Any of the following criteria will make the patient ineligible to participate in this study:

• 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 investigational agent(s).

Patients received cetuximab, 400 mg/mg2 over 2 h on Day 1 then 250 mg/m2/week over 1 h, for 5 additional weeks. Patients also received paclitaxel, 50 mg/m2/week, over 1 h and carboplatin AUC (area under the curve) = 2/week, over 30 min, for 6 weeks. Cetuximab was administered first.

For 30 days post end of treatment, approximately 6 months.

CTCAE v 3