Panitumumab, Combination Chemotherapy, & Radiation Therapy in Esophageal or Gastroesophageal Junction Cancer
Condition: Adenocarcinoma of the Gastroesophageal Junction; Esophageal Adenocarcinoma; Stage IIA Esophageal Cancer; Stage IIB Esophageal Cancer
MeSH terms: Adenocarcinoma; Esophageal Neoplasms
Intervention: Fluorouracil; Laboratory Biomarker Analysis; Leucovorin Calcium; Oxaliplatin; Panitumumab; Pharmacological Study; Radiation Therapy; Therapeutic Conventional Surgery
Intervention description: Given IV; Correlative studies; Given IV; Given IV; Given IV; Correlative studies; Undergo radiation therapy; Undergo surgical resection
Intervention MeSH terms: Calcium, Dietary; Leucovorin; Folic Acid; Antineoplastic Agents, Immunological; Panitumumab; Fluorouracil; Oxaliplatin; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Calcium; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well giving panitumumab, combination chemotherapy, and
      radiation therapy together before surgery works in treating patients with advanced esophageal
      or gastroesophageal (GE) junction cancer. Monoclonal antibodies, such as panitumumab, may
      interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,
      such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the
      growth of tumor cells, either by killing the cells, by stopping them from dividing, or by
      stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells.
      Giving monoclonal antibody therapy together with chemotherapy and radiation therapy before
      surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be
      removed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have resectable adenocarcinoma of the esophagus or GE-junction and are
             medically fit to undergo surgery; patients must have no evidence of distant metastasis
             based on imaging studies

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Absolute neutrophil count (ANC) of at least 2000 per mcL

          -  Platelet count of at least 100,000 per mcL

          -  Serum creatinine less than or equal to 2.0 mg/dL

          -  Serum magnesium greater than or equal to 1.8 mg/dL

          -  Total bilirubin less than or equal to 2.0 mg per dL

          -  Measurable disease is not required for this study, since the primary endpoint is
             complete pathologic response

          -  The patient must be aware of the neoplastic nature of his/her disease and willingly
             provide written, informed consent after being informed of the procedure to be
             followed, the experimental nature of the therapy, alternatives, potential benefits,
             side-effects, risks, and discomforts

        Exclusion Criteria:

          -  Prior therapy: patients with prior history of mediastinal radiation exposure will be
             ineligible; patients may not have received prior chemotherapy, or antibody therapy for
             esophageal or GE-junction adenocarcinoma

          -  History of allergy to platinum compounds or to antiemetics appropriate for
             administration in conjunction with protocol-directed chemotherapy

          -  Patients with a prior history of marked intolerance to 5-fluoropyrimidines (5-FU,
             floxuridine, capecitabine, 5-fluorocytosine [flucytosine]), since such patients may
             have deficiency of dihydropyrimidine dehydrogenase, which places them at risk for
             severe and life-threatening toxicity with 5-FU

          -  Uncontrolled inter-current illness including, but not limited to ongoing or active
             infection requiring intravenous antibiotics, ongoing immunosuppressive therapy (except
             for replacement steroids), active human immunodeficiency virus (HIV) infection, that
             might jeopardize the ability of the patient to receive the chemotherapy program
             outlined in this protocol with reasonable safety

          -  Clinically significant cardiac disease (including symptomatic congestive heart
             failure, myocardial infarction, unstable angina pectoris, or serious, uncontrolled
             cardiac arrhythmia) within 1 year of study enrollment

          -  Pregnant and nursing women, or women planning to become pregnant within 6 months after
             the end of treatment, are excluded from this study; a negative pregnancy test will be
             required of women of child-bearing age within 72 hours of study enrollment; subjects
             (male or female) who are not willing to use highly effective methods of contraception
             (per institutional standard) during treatment and for 6 months (male or female) after
             the end of treatment are excluded

          -  History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or
             evidence of interstitial lung disease on baseline chest computed tomography (CT) scan

          -  Patients with prior malignancy will be excluded except for adequately treated basal
             cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or other
             cancers from which the patient has been disease-free for at least 5 years

          -  Patients receiving an investigational agent within 30 days before enrollment