Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00237900
Recruitment Status : Terminated
First Posted : October 13, 2005
Last Update Posted : April 23, 2009
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Brief Summary:
To assess safety, efficacy and explorative objectives of gefitinib in combination with chemoradiation in resectable gastric cancer

Condition or disease Intervention/treatment 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  (Clinical Trial)
Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2003
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Primary Outcome Measures :
  1. Part 1: Safety and tolerability of gefitinib 250 mg in combination with radiotherapy (incidence of DLTs)
  2. Parts 2 and 3: Safety and tolerability of gefitinib in combination with 5-FU, LV and radiotherapy

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

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00237900

Reseach Site
Helsinki, Finland
Sponsors and Collaborators
Study Director: AstraZeneca Oncology Medical Science Director, MD AstraZeneca Identifier: NCT00237900     History of Changes
Other Study ID Numbers: 1839IL/0539
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: April 23, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors