gefitinib in treating patients with locally advanced esophageal cancer

Conditions: Esophageal Cancer

Summary: rationale: gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. purpose: this phase ii trial is studying how well gefitinib works in treating patients with locally advanced esophageal cancer.

objectives: primary * determine the 1-year overall survival rate in patients with previously treated locally advanced adenocarcinoma of the esophagus or gastroesophageal junction treated with gefitinib as maintenance therapy. secondary * determine disease-free survival and time to disease recurrence in patients treated with this drug. * determine the toxicity of this drug in these patients. * determine the quality of life of patients treated with this drug. outline: this is a multicenter study. patients receive oral gefitinib once daily on days 1-28. courses repeat every 28 days in the absence of disease recurrence or unacceptable toxicity. quality of life is assessed at baseline, 4 weeks, every 12 weeks during study treatment, and then at the end of study treatment. patients are followed every 3 months for up to 5 years.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction * locally advanced disease * t3 or t4 tumor with no lymph node involvement or any t stage with local lymph node involvement * celiac node involvement allowed * no supraclavicular lymph node involvement * received potentially curative chemotherapy, radiotherapy, and/or surgery within the past 1-3 months * patients who received adjuvant chemotherapy or chemoradiotherapy after surgery are eligible provided last treatment was administered within the past 3 months * no evidence of residual tumor or metastatic disease after undergoing potentially curative therapy * no positive margins at the time of prior surgery * no measurable or evaluable disease patient characteristics: age * 18 and over performance status * ecog 0-2 life expectancy * at least 12 weeks hematopoietic * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 hepatic * bilirubin ≤ 2.0 mg/dl renal * creatinine ≤ 2 times upper limit of normal cardiovascular * no new york heart association class iii or iv heart disease other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * able to swallow study drug * no other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma prior concurrent therapy: biologic therapy * not specified chemotherapy * see disease characteristics endocrine therapy * not specified radiotherapy * see disease characteristics surgery * see disease characteristics other * no prior gefitinib * no concurrent cyp3a4 inducing agents, including any of the following: * carbamazepine * oxcarbazepine * modafinil * ethosuximide * griseofulvin * nafcillin * phenobarbital * phenylbutazone * phenytoin * primidone * rifampin * hypericum perforatum (st. john's wort) * sulfinpyrazone * no concurrent antacids 4 hours before or after study drug administration

Keywords: adenocarcinoma of the esophagus stage ii esophageal cancer