Cetuximab, Paclitaxel, Carboplatin & Radiation for Esoph, Gastroesoph & Gastric Cancer

Phase 2

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
Treatment	Cetuximab,Paclitaxel, Carboplatin	Cetuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation.

Primary Outcome Measures

Name	Time	Method
Reponse Rate at Time of Surgery by Tissue	within 30 days of last treatment	pathologic complete response rate at surgery

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Grade 2 and/or 3 Rash in Patients With Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus, Gastroesophageal Junction, or Stomach.	baseline, then during treatment, about 5 weeks through 30 days post treatment.	CTCAE version 3: grade 2 and 3 rash. This is reported as it was the most common toxicity.