Gefitinib 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.

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