Neoadjuvant Therapy of Gastric Cancer With Irinotecan, Cisplatin and Cetuximab Followed by Surgical Resection and Adjuvant Chemoradiation
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 efficacy of adding an antibody blocking the EGF pathway to a neoadjuvant
approach with proven efficacy developed at New York University. The combination of
Irinotecan and Cisplatin has been shown to be synergistic and active against gastric
carcinoma. This trial therefore builds upon our previous experience with the neoadjuvant
administration of Irinotecan combined with Cisplatin as well as the reported enhanced
activity of Irinotecan, Cisplatin and External beam radiation when combined with Cetuximab
to develop a novel neoadjuvant and adjuvant approach for the treatment of gastric and
esophago-gastric junction (GEJ) cancers. The program includes: 1) systemic combination of
Irinotecan, Cisplatin and Cetuximab used as an induction, 2) followed by potentially
curative gastrectomy or GEJ resection, and 3) post-operative chemoradiation as reported in
the Intergroup study with the addition of Cetuximab.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
clinical response rate (RR) of an induction regimen consisting of Irinotecan, Cisplatin and Cetuximab
4 months from the beginning of the induction regimen
No
Theresa Ryan, MD
Principal Investigator
New York University School of Medicine
United States: Institutional Review Board
04-72 (H12637)
NCT00857246
July 2005
March 2014
Name | Location |
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NYU Cancer Center | New York, New York 10016 |