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

Completed · Phase 2

Conditions studied: Gastric Cancer, Stomach Cancer

In brief

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.

Key facts

Study ID

NCT00857246

Run by

NYU Langone Health

People needed

30

Starts

2005-07-01

Expected to finish

2015-10-01

Last updated by the study team

2015-12-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• NYU Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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