Status:
COMPLETED
Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Bristol-Myers Squibb
Eli Lilly and Company
Conditions:
Gastric Cancer
Stomach Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
The overall objective of this study is the development of definitive treatments for patients with locally advanced gastric cancer. To this end, this trial is evaluating the feasibility and treatment e...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00857246
Start Date
July 1 2005
End Date
October 1 2015
Last Update
December 7 2015
Active Locations (1)
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1
NYU Cancer Center
New York, New York, United States, 10016