Gefitinib in Treating Patients With Locally Advanced Esophageal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary 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. Secondary 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.

Official Title
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A Phase II Study Of Maintenance ZD1839 (IRESSA) In Patients With Locally Advanced Esophageal Cancer After Treatment Given With Curative Intent

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: gefitinib


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 2.0 mg/dL Renal Creatinine ≤ 2 times upper limit of normal Cardiovascular No New York Heart Association class III or IV heart disease Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy See Disease Characteristics Surgery See Disease Characteristics Other 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gefitinib<br>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. | Drug: gefitinib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year overall survival rate |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival time |  | Up to 5 years | 
| Disease-free survival |  | Up to 5 years | 
| Time to disease recurrence |  | Up to 5 years | 
| Time to treatment failure |  | Up to 5 years | 
| Quality of life |  | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the esophagus, stage II esophageal cancer