Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer

April 22, 2009 updated by: AstraZeneca

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

34

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Reseach Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Aged below 45 or over 70
  • Prior gastric surgery
  • Active ILD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Oncology Medical Science Director, MD, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

October 12, 2005

First Submitted That Met QC Criteria

October 12, 2005

First Posted (Estimate)

October 13, 2005

Study Record Updates

Last Update Posted (Estimate)

April 23, 2009

Last Update Submitted That Met QC Criteria

April 22, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1839IL/0539

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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