Gefitinib in Treating Patients With Recurrent or Metastatic Esophageal or Gastroesophageal Junction Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: ZD1839
Intervention description: ZD1839 treatment will be taken once a day PO, every day about the same time
Intervention MeSH terms: Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the esophagus; recurrent esophageal cancer; squamous cell carcinoma of the esophagus; stage IV 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
      recurrent or metastatic esophageal or gastroesophageal junction cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Pathologically confirmed squamous cell carcinoma, adenocarcinoma, or large-cell
             undifferentiated carcinoma of the esophagus or gastroesophageal junction

               -  Patients must have disease that is either metastatic (i.e., M1b by the
                  definitions of the American Joint Committee on Cancer 1997 staging system) or
                  recurrent after definitive therapy, and must be considered incurable by
                  conventional treatments

               -  Patients with small cell, or mixed small cell/non-small-cell histology are
                  ineligible

               -  Patients with lymphoma or sarcoma are also ineligible

          -  Disease must be measurable in at least one dimension by physical exam, x-ray, CT scan
             or MRI, ultrasound, or endoscopy

               -  Measurable disease can be a previously irradiated lesion if disease growth has
                  been documented in the lesion since completion of radiation therapy

               -  An elevation in carcinoembryonic antigen (CEA) is not sufficient to use by itself
                  in response assessment

        PATIENT CHARACTERISTICS:

          -  ECOG Performance Status 0-1

          -  WBC ≥ 3,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Creatinine ≤ 2.0 mg/dL

          -  Alkaline phosphatase and AST < twice normal

          -  Bilirubin < twice normal

          -  Calcium normal

          -  No known severe hypersensitivity to study drug or any of its excipients

          -  No clinical evidence of any other uncontrolled malignancy except adequately treated
             basal or squamous cell skin cancer or in situ cervical cancer

          -  Pregnant or nursing women are ineligible

          -  Fertile patients must use effective contraception

          -  No evidence of severe or uncontrolled systemic disease (e.g., unstable or
             uncompensated respiratory, cardiac, hepatic, or renal disease)

          -  No evidence of clinically active interstitial lung disease

               -  Patients with chronic stable radiographic changes who are asymptomatic need not
                  be excluded

        PRIOR CONCURRENT THERAPY:

          -  Patients may not have received more than one previous systemic treatment regimen

               -  Systemic treatment may have been given as part of definitive (adjuvant,
                  neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent
                  disease

               -  Previously untreated patients are also eligible

          -  No previous treatment with study drug or any other epidermal growth factor receptor
             (EGFR) antagonists

          -  More than 30 days since prior treatment with a non-approved or investigational drug

          -  At least 4 weeks must have elapsed since any surgery, radiation therapy, or
             chemotherapy administration

          -  Recovered from previous oncologic or other major surgery

          -  No concurrent barbiturates (e.g., phenytoin), carbamazepine, rifampicin, phenobarbital
             or Hypericum perforatum (St. John's wort)

          -  No concurrent surgery, radiation therapy, hormonal therapy, or other chemotherapy