S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: cetuximab
Intervention description: 1 time Cetuximab 400mg/m2 IV over 120 minutes followed by weekly Cetuximab 250mg/m2 IV over 60 minutes.
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the esophagus; recurrent esophageal cancer; stage IV esophageal cancer

Summary:

      RATIONALE: Biological therapies such as cetuximab may stop the growth of tumor cells by
      blocking the enzymes necessary for their growth.

      PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with
      metastatic esophageal cancer or gastroesophageal junction cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of 1 of the following sites:

               -  Thoracic esophagus, located > 20 cm* from the incisors

               -  Gastroesophageal junction, located ≤ 2 cm into the gastric cardia NOTE: *Tumors
                  located < 26 cm from the incisors must be confirmed by bronchoscopy and negative
                  cytology

          -  Disease confined to the esophagus and periesophageal soft tissue

          -  Metastatic disease

          -  Measurable disease by x-ray, scanning, or physical examination

          -  Received exactly 1 prior chemotherapy regimen for metastatic or recurrent disease

               -  One prior adjuvant or neoadjuvant chemotherapy regimen allowed if administered at
                  the time of initial diagnosis with localized disease

          -  No known brain metastases

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Granulocyte count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  Not specified

        Renal

          -  Creatinine ≤ 1.5 times upper limit of normal

        Other

          -  No prior allergic reaction to chimerized or murine monoclonal antibodies

          -  No evidence of human anti-mouse antibodies (HAMA)

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
             stage I or II cancer in complete remission

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior cetuximab

        Chemotherapy

          -  See Disease Characteristics

          -  At least 4 weeks since prior chemotherapy and recovered

          -  No concurrent chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  At least 4 weeks since prior radiotherapy and recovered

        Surgery

          -  At least 3 weeks since prior thoraco-abdominal surgery and recovered

        Other

          -  No other prior therapy that specifically targets the epidermal growth factor pathway

          -  No other concurrent investigational agents