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Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer

This study has been terminated.
Information provided by:
AstraZeneca Identifier:
First received: October 12, 2005
Last updated: April 22, 2009
Last verified: April 2009

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

Condition Intervention Phase
Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GC
Drug: Gefitinib, 5-fluorouracil, leucovorin and radiotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 34
Study Start Date: July 2003
Study Completion Date: February 2004

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00237900

Reseach Site
Helsinki, Finland
Sponsors and Collaborators
Study Director: AstraZeneca Oncology Medical Science Director, MD AstraZeneca
  More Information

No publications provided Identifier: NCT00237900     History of Changes
Other Study ID Numbers: 1839IL/0539
Study First Received: October 12, 2005
Last Updated: April 22, 2009
Health Authority: Finland: Finnish Medicines Agency processed this record on March 03, 2015