Paclitaxel, Cisplatin, Gefitinib, and Radiation Therapy Followed by Surgery and Gefitinib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction That Can Be Removed By Surgery

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction meeting the following criteria:

  • Newly diagnosed disease
  • Surgically resectable tumor
  • Primary esophageal tumor \< 20 cm below the incisors
  • Tumor extending ≤ 2 cm into the cardia

• Stage T2-3, N0-1, M0-1a tumor, as determined by imaging studies and biopsy

  • Documentation by endoscopic ultrasound, endoscopy, and CT scan of the chest and abdomen required
  • Any lesion suspicious for metastasis must be biopsied
  • M1a disease (i.e., celiac nodal metastasis) is allowed if other eligibility criteria are met
  • T4 disease (i.e., involvement of the pleura, pericardium, or diaphragm) allowed provided it is considered resectable
• No CNS metastasis
• ECOG performance status 0-1
• Granulocyte count > 1,000/mm³
• Platelet count > 75,000/mm³
• Creatinine clearance > 60 mL/min
• Total bilirubin \< 1.5 mg/dL
• No concurrent illness likely to preclude protocol therapy or surgical resection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study therapy Exclusion Criteria
• Known severe hypersensitivity to gefitinib or any of its excipients
• Evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
• Evidence of other significant clinical disorder or laboratory finding that would preclude study participation
• Evidence of clinically active interstitial lung disease
• Chronic, stable radiographic changes that are asymptomatic are eligible
• Prior or concurrent malignancy except basal cell or squamous cell skin cancer, cervical cancer, or any other curatively treated malignancy from which the patient has been disease-free and has a survival prognosis of > 5 years
• Preexisting peripheral neuropathy > grade 1
• Incomplete healing from prior oncologic or other major surgery
• Prior chemotherapy, radiotherapy, or surgery for this cancer
• More than 30 days since prior nonapproved or investigational drugs
• Concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or Hypericum perforatum (St. John's wort)
• Concurrent oral retinoids