Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study intends to evaluate the feasibility and treatment efficacy of adding an antibody blocking the epidermal growth factor (EGF) pathway to a neoadjuvant approach with proven efficacy developed at New York University.

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

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborators: Bristol-Myers Squibb; Eli Lilly and Company; ImClone LLC
• Treatments: Antibodies; Cetuximab; Cisplatin; Irinotecan

Criteria

Inclusion Criteria:

• Patients must have signed an approved informed consent.

• must have histologically documented untreated gastric/GEJ carcinoma (clinical stage T3 N0 or T4, or any T with N1-N3 M0)

• Patients with tumor tissue available for assessment of EGF receptor status by immuno-histochemistry (IHC).

• Patients with Performance Status 0-2.

• Patients, 18 years and older, must either be not of child bearing potential or have a negative pregnancy test within 7 days of 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.

• Bone marrow function: absolute neutrophil count (ANC) at least 1,500/ul; platelets at least 100,000/ul.

• Renal function: creatinine not greater than 1.5 x institutional upper limit of normal (ULN).

• The PT and PTT should be within the range of normal values

• Hepatic function: bilirubin not greater than 1.5 x ULN; aspartate aminotransferase (AST) not greater than 2.5 x ULN.

Exclusion Criteria:

• Acute hepatitis or known HIV.

• Active or uncontrolled infection.

• Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, and congestive heart failure.

• Prior therapy that affects or targets the EGF pathway.

• Prior allergic reaction to chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies (HAMA).

• Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).