Gefitinib in Treating Patients With Esophageal Cancer That is Progressing After Chemotherapy

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: NCT01243398
Recruitment Status : Completed
First Posted : November 18, 2010
Last Update Posted : November 29, 2012
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether gefitinib is more effective than a placebo in treating esophageal cancer.

PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works compared with a placebo in treating patients with esophageal cancer that is progressing after chemotherapy.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Gastroesophageal Junction Esophageal Cancer Procedure: quality-of-life assessment Phase 3

Detailed Description:



  • To assess whether gefitinib vs placebo will improve overall survival of patients with esophageal or gastroesophageal junction cancer.


  • To assess the toxicity of gefitinib monotherapy in these patients.
  • To assess whether gefitinib vs placebo will have a significant positive or negative impact upon quality of life of these patients.
  • To assess the impact gefitinib vs placebo will have on progression-free survival of these patients.

OUTLINE: This is a multicenter study.

  • Arm A: Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
  • Arm B: Patients receive oral placebo once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Blood samples are collected for genetic and translational studies. Patient's quality of life is assessed at baseline and periodically during the study with completion of EORTC Quality of Life Questionnaire (QLQ-C30) version 3.0.

After completion of study treatment, patients are followed up every 8 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gefitinib (Iressa®) Versus Placebo in Esophageal Cancer Progressing After Chemotherapy
Study Start Date : March 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Gefitinib 500mg once daily
Gefitinib 500mg once daily
Procedure: quality-of-life assessment
Placebo Comparator: Placebo
Gefitinib 500mg once daily
Procedure: quality-of-life assessment

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 4, 8, 12, 16 weeks then every 8 weeks ]

Secondary Outcome Measures :
  1. Toxicity and safety [ Time Frame: 4, 8, 12, 16 weeks then every 8 weeks ]
  2. Quality of life [ Time Frame: 4, 8 and 12 weeks ]
  3. Progression-free survival [ Time Frame: 4, 8, 12, 16 weeks then every 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed esophageal cancer or gastroesophageal junction tumor including the following subtypes:

    • Adenocarcinoma
    • Squamous cell cancer
    • Poorly differentiated epithelial malignancy
    • Gastroesophageal junction with Siewert type I or II tumors
  • Failure after no more than 2 prior chemotherapy regimens and 1 chemoradiation course
  • Measurable or evaluable disease by CT scan
  • Patients with brain metastases must be stable and have received cranial irradiation prior to entry


  • WHO performance status 0-2
  • Serum bilirubin ≤ 3 times the upper limit of normal (ULN)
  • AST/ALT ≤ 2.5 times ULN (≤ 5 x in presence of liver metastases)
  • Able to take oral tablets (whole or dispersed)
  • No evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic allowed)
  • No known severe hypersensitivity to gefitinib or any of the excipients of this product
  • No prior other malignancy likely to confound results or interfere with gefitinib therapy
  • No medical condition considered to interfere with the safe participation in the trial
  • Not pregnant
  • Fertile patients must use effective contraception


  • See Disease Characteristics
  • No chemotherapy (including oral) within the past 6 weeks
  • No radiotherapy to site of measurable or evaluable disease within the past 4 weeks
  • No other concurrent cytotoxic chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids) or experimental medications

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): NCT01243398

United Kingdom
New Cross Hospital
Wolverhampton, England, United Kingdom, WV10 0QP
Sponsors and Collaborators
University of Oxford
Principal Investigator: David Ferry, MD New Cross Hospital

Responsible Party: University of Oxford Identifier: NCT01243398     History of Changes
Other Study ID Numbers: CDR0000689080
First Posted: November 18, 2010    Key Record Dates
Last Update Posted: November 29, 2012
Last Verified: November 2012

Keywords provided by University of Oxford:
adenocarcinoma of the gastroesophageal junction
adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus
recurrent esophageal cancer
stage IA esophageal cancer
stage IB esophageal cancer
stage IIA esophageal cancer
stage IIB esophageal cancer
stage IIIA esophageal cancer
stage IIIB esophageal cancer
stage IIIC esophageal cancer
stage IV esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action