Gefitinib in Treating Patients With Locally Advanced Esophageal Cancer

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: January 7, 2005
Last updated: October 13, 2009
Last verified: October 2009

January 7, 2005
October 13, 2009
July 2005
October 2009   (final data collection date for primary outcome measure)
1-year overall survival rate [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00100945 on Archive Site
  • Survival time [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Time to disease recurrence [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
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Gefitinib in Treating Patients With Locally Advanced Esophageal Cancer
A Phase II Study Of Maintenance ZD1839 (IRESSA) In Patients With Locally Advanced Esophageal Cancer After Treatment Given With Curative Intent

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with locally advanced esophageal cancer.



  • Determine the 1-year overall survival rate in patients with previously treated locally advanced adenocarcinoma of the esophagus or gastroesophageal junction treated with gefitinib as maintenance therapy.


  • Determine disease-free survival and time to disease recurrence in patients treated with this drug.
  • Determine the toxicity of this drug in these patients.
  • Determine the quality of life of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease recurrence or unacceptable toxicity.

Quality of life is assessed at baseline, 4 weeks, every 12 weeks during study treatment, and then at the end of study treatment.

Patients are followed every 3 months for up to 5 years.

PROJECTED ACCRUAL: A total of 26-72 patients will be accrued for this study within 9-24 months.

Phase 2
Masking: Open Label
Primary Purpose: Treatment
Esophageal Cancer
  • Drug: gefitinib
  • Procedure: adjuvant therapy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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October 2009   (final data collection date for primary outcome measure)


  • Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction

    • Locally advanced disease

      • T3 or T4 tumor with no lymph node involvement OR any T stage with local lymph node involvement

        • Celiac node involvement allowed
        • No supraclavicular lymph node involvement
  • Received potentially curative chemotherapy, radiotherapy, and/or surgery within the past 1-3 months

    • Patients who received adjuvant chemotherapy or chemoradiotherapy after surgery are eligible provided last treatment was administered within the past 3 months
  • No evidence of residual tumor or metastatic disease after undergoing potentially curative therapy

    • No positive margins at the time of prior surgery
    • No measurable or evaluable disease



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin ≤ 2.0 mg/dL


  • Creatinine ≤ 2 times upper limit of normal


  • No New York Heart Association class III or IV heart disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to swallow study drug
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma


Biologic therapy

  • Not specified


  • See Disease Characteristics

Endocrine therapy

  • Not specified


  • See Disease Characteristics


  • See Disease Characteristics


  • No prior gefitinib
  • No concurrent CYP3A4 inducing agents, including any of the following:

    • Carbamazepine
    • Oxcarbazepine
    • Modafinil
    • Ethosuximide
    • Griseofulvin
    • Nafcillin
    • Phenobarbital
    • Phenylbutazone
    • Phenytoin
    • Primidone
    • Rifampin
    • Hypericum perforatum (St. John's wort)
    • Sulfinpyrazone
  • No concurrent antacids 4 hours before or after study drug administration
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000407534, NCCTG-N0342
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North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: Aminah Jatoi, MD Mayo Clinic
Investigator: George P. Kim, MD Mayo Clinic
Investigator: Jeff Sloan, PhD Mayo Clinic
National Cancer Institute (NCI)
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP