Trial intelligence / Profile preview

Neoadjuvant Cetuximab, Irinotecan, and Cisplatin in Gastric Cancer

NCT00857246Phase 2

Key facts

Status: Completed
Start: Jul 2005
Primary completion: Sep 2011
Countries: 1
Sponsor: NYU Langone Health
Modality: Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies

Drugs: cetuximab
Conditions: gastric cancer (GC)

Overview

Phase 2, open-label, single-arm trial of cetuximab in gastric cancer (GC), sponsored by NYU Langone Health. Primary endpoint: Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab at 4 months. Started Jul 2005; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Induction/ surgery/ chemoRT
Induction with Cisplatin/Irinotecan/Cetuximab, followed by Surgery, followed by Adjuvant Chemoradiation with Cetuximab/5-FU/Radiation

Endpoints

Primary

Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab4 months

Secondary

Rate of Clearance of Nodal Involvement Among Patients Who Have Received the Induction Therapy4 months
Rate of Potentially Curative Surgery4 months
Rate of "Down-staging" From Pre-operative Clinical Staging4 months
Safety of the Induction Regimen4 months
Median Overall Survival (Induction Treatment and Curative Surgery)5 years
Median Overall Survival (Adjuvant Therpary)5 years

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