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Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By Surgery

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: NCT00258297
Recruitment Status : Terminated (Withdrawn for lack of funding and accrual)
First Posted : November 24, 2005
Last Update Posted : October 16, 2013
Information provided by (Responsible Party):
University of Rochester

Brief Summary:

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage I, stage II, or stage III esophageal cancer that can be removed by surgery.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: gefitinib Procedure: conventional surgery Procedure: enzyme inhibitor therapy Procedure: neoadjuvant therapy Procedure: protein tyrosine kinase inhibitor therapy Procedure: surgery Phase 2

Detailed Description:



  • Determine the safety and tolerability of neoadjuvant gefitinib in patients with resectable stage I-III esophageal cancer.


  • Determine the epidermal growth factor-receptor expression in tissue samples obtained at diagnosis and surgery from patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive oral gefitinib once daily beginning between days -21 and -14 and continuing until day -1. Patients undergo tumor resection on day 0.

After completion of study treatment, patients are followed periodically for 6 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Safety, Efficacy, and Feasibility Study of Neoadjuvant ZD1839 (IRESSA) in Resectable Esophageal Cancer
Study Start Date : April 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Primary Outcome Measures :
  1. Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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


  • Histologically confirmed squamous cell or adenocarcinoma of the thoracic esophagus

    • Resectable, localized disease with or without metastases in local lymph nodes (T1, T2, or T3; any N; M0)
    • Stage I-III disease
  • No known distant metastases
  • No cervical-esophageal tumors (upper border < 18 cm from the incisor teeth)
  • No supraclavicular metastases


Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Adequate bone marrow function


  • Adequate hepatic function
  • No unstable or uncompensated hepatic disease


  • Creatinine ≤ grade 2 by Common Toxicity Criteria
  • Adequate renal function
  • No unstable or uncompensated renal disease


  • No unstable or uncompensated cardiac disease


  • No clinically active interstitial lung disease unless it is asymptomatic with chronic stable radiographic changes
  • No unstable or uncompensated respiratory disease


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No known hypersensitivity to gefitinib or any of the excipients
  • No other malignancy within the past 2 years except basal cell carcinoma or carcinoma in situ of the cervix
  • No evidence of severe or uncontrolled systemic disease
  • No other significant clinical disorder or laboratory finding that would preclude study participation


Endocrine therapy

  • Concurrent stable-dose steroids allowed


  • Recovered from any prior oncologic or other major surgery


  • More than 30 days since prior nonapproved or investigational drug
  • No prior therapy for this or any other malignancy
  • No concurrent phenytoin, carbamazepine, barbiturates, rifampin, or Hypericum perforatum (St. John's wort)

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): NCT00258297

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United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
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Study Chair: Kishan J. Pandya, MD James P. Wilmot Cancer Center

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Responsible Party: University of Rochester Identifier: NCT00258297    
Other Study ID Numbers: CDR0000447159
First Posted: November 24, 2005    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013
Keywords provided by University of Rochester:
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Enzyme Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action