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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brown University
• Collaborator: Bristol-Myers Squibb
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cetuximab; Paclitaxel

Criteria

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).