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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01243398
First received: November 17, 2010
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 4, 8, 12, 16 weeks then every 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity and safety [ Time Frame: 4, 8, 12, 16 weeks then every 8 weeks ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 4, 8, 12, 16 weeks then every 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 450
Study Start Date: March 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243398

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

Additional Information:
No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01243398     History of Changes
Other Study ID Numbers: CDR0000689080, OXFORD-COG, UO-COG, EUDRACT-2007-005391-13, ISRCTN-29580179, AZ-D7913L00059, EU-21085
Study First Received: November 17, 2010
Last Updated: November 28, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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:
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014