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

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. 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.

Detailed Description
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OBJECTIVES: Primary Determine the safety and tolerability of neoadjuvant gefitinib in patients with resectable stage I-III esophageal cancer. Secondary 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.

Official Title
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A Phase II Safety, Efficacy, and Feasibility Study of Neoadjuvant ZD1839 (IRESSA) in Resectable Esophageal Cancer

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: gefitinib
* Procedure: conventional surgery
* Procedure: enzyme inhibitor therapy
* Procedure: neoadjuvant therapy
* Procedure: protein tyrosine kinase inhibitor therapy
* Procedure: surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Adequate bone marrow function Hepatic Adequate hepatic function No unstable or uncompensated hepatic disease Renal Creatinine ≤ grade 2 by Common Toxicity Criteria Adequate renal function No unstable or uncompensated renal disease Cardiovascular No unstable or uncompensated cardiac disease Pulmonary No clinically active interstitial lung disease unless it is asymptomatic with chronic stable radiographic changes No unstable or uncompensated respiratory disease Other 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 PRIOR CONCURRENT THERAPY: Endocrine therapy Concurrent stable-dose steroids allowed Surgery Recovered from any prior oncologic or other major surgery Other 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)

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gefitinib|nan|
|Procedure: conventional surgery|nan|
|Procedure: enzyme inhibitor therapy|nan|
|Procedure: neoadjuvant therapy|nan|
|Procedure: protein tyrosine kinase inhibitor therapy|nan|
|Procedure: surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus