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