An Open, Single.Centre, Phase I/II Study of ZD1839 (Iressa) in Combination With 5-Fluorouracil, Leucovorin and Radiotherapy in Subjects With Resectable Gastric Cancer

AstraZeneca1 site in 1 country34 target enrollmentJuly 2003

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GC
Sponsor: AstraZeneca
Enrollment: 34
Locations: 1
Primary Endpoint: Part 1: Safety and tolerability of gefitinib 250 mg in combination with radiotherapy (incidence of DLTs)
Status: Terminated
Last Updated: 17 years ago

To assess safety, efficacy and explorative objectives of gefitinib in combination with chemoradiation in resectable gastric cancer

Registry

clinicaltrials.gov

Start Date

July 2003

End Date

February 2004

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

•Histologically-confirmed intestinal GC (T2-T4)
•Local or locally advanced stage II or stage III gastric cancer of an upper part of the stomach or GE junction
•Lymph node positive or negative
•Metastasis negative
•Resection with curative intent (R0, D2)
•Chemo- and radiotherapy naïve
•Measurable lesion according RECIST
•Written informed consent

Part 1: Safety and tolerability of gefitinib 250 mg in combination with radiotherapy (incidence of DLTs)

Parts 2 and 3: Safety and tolerability of gefitinib in combination with 5-FU, LV and radiotherapy

Parts 2 and 3:
Objective tumour response rate a week before surgery (CR and PR, RECIST criteria).
Objective histological response rate in dissected GC specimens taken at surgery, estimated using Evans/Pisters scores
Exploratory outcome: Parts 2 and 3: sVEGF levels, EGFR activation, Biomarkers such as cyclin D1, IL-1, GI-associated TOP2A, GAS, EST AA552509