Gefitinib in Treating Patients With Locally Advanced Esophageal Cancer

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