Gefitinib, Cisplatin, Irinotecan, and Radiation Therapy Before Surgery in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery
Esophageal Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma (AC) or squamous cell carcinoma of the esophagus AC of the gastroesophageal junction allowed Tumor must be considered surgically resectable (T1-3, NX) No early-stage cancer (T1, N0) The following lymph node (LN) criteria are considered acceptable: Regional thoracic LN metastases (N1) LN metastases levels 15 to 20 measured as ≤ 1.5 cm by CT scan Supraclavicular LN not palpable on clinical examination measured as ≤ 1.5 cm by CT scan No distant metastases (M0) PATIENT CHARACTERISTICS: Platelet count ≥ 100,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Hemoglobin ≥ 9.0 g/dL Creatinine clearance ≥ 50 mL/min Creatinine serum level ≤ CTC grade 2 Bilirubin ≤ 2 times upper limit of normal (ULN) AST < 3 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment No known severe hypersensitivity to gefitinib or any of its excipients No evidence (except asymptomatic chronic stable radiographic changes) of clinically active interstitial lung disease No pulmonary fibrosis, Gilbert's disease, uncontrolled diabetes mellitus, or unstable angina No New York Heart Association class III or IV heart disease No other concurrent malignancies or malignancies diagnosed within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix No serious active or uncontrolled infection, systemic disease, psychiatric illness, or other medical condition that would preclude study participation No evidence of any significant clinical disorder or laboratory finding that would preclude study participation PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy for esophageal cancer No prior radiotherapy that would overlap the study treatment fields Recovered from prior major surgery No nonapproved or investigational drugs within the past 30 days No concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or Hypericum perforatum (St. John's wort)
Sites / Locations
- UCSF Helen Diller Family Comprehensive Cancer Center