Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By Surgery
Esophageal Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus
Eligibility Criteria
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)
Sites / Locations
- James P. Wilmot Cancer Center at University of Rochester Medical Center