• Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib
  

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.

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)