Oxaliplatin, Capecitabine, and Radiation Therapy in Patients Undergoing Surgery for Stage II, III, IV Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: capecitabine; oxaliplatin; gene expression analysis; microarray analysis; reverse transcriptase-polymerase chain reaction; adjuvant therapy; biopsy; conventional surgery; neoadjuvant therapy; quality-of-life assessment; radiation therapy
Intervention description: Oral; IV; Correlative Study; Correlative Study; Correlative Study; Metastatic growth control; Examination of tissue type; Tissue removal; Tumor shrinkage; Correlative Study; Undergoing radiation therapy
Intervention MeSH terms: Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the esophagus; squamous cell carcinoma of the esophagus; stage II esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving
      chemotherapy together with radiation therapy before surgery may make the tumor smaller and
      reduce the amount of normal tissue that needs to be removed.

      PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine
      together with radiation therapy works in treating patients undergoing surgery for stage II,
      stage III, or stage IV esophageal cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of squamous cell carcinoma of the esophagus or adenocarcinoma of the
             esophagus

               -  Stage II-IVA disease as determined by clinical staging, including endoscopy and
                  CT scan with or without endoscopic ultrasound

               -  Bulk of gastroesophageal junction tumor should be in the esophagus

          -  Bronchoscopy with biopsy and cytology required if primary esophageal cancer is < 26 cm
             from incisors

          -  No known brain metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Life expectancy > 4 months

          -  WBC > 4,000/mm³

          -  ANC > 1,500/mm³

          -  Platelet count > 100,000/mm³

          -  Hemoglobin > 9 g/dL

          -  Bilirubin normal

          -  Creatinine normal

          -  AST < 2.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 3 times ULN

          -  Able to take oral medication or undergo enteral administration of medication

          -  No peripheral neuropathy ≥ grade 2

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 90 days after
             completion of study treatment

          -  No hypersensitivity to platinum compounds, fluoropyrimidines, or antiemetics
             administered in combination with protocol-directed chemotherapy

          -  No concurrent uncontrolled illness, including, but not limited to, any of the
             following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness or social situation that would preclude study compliance

          -  No history of second malignancy except for curatively treated carcinoma in situ of the
             cervix or nonmelanoma skin cancer

               -  Other cured tumors allowed at discretion of the principal investigator

          -  No known HIV or hepatitis B or C (active and/or previously treated)

        PRIOR CONCURRENT THERAPY:

          -  No prior therapy for esophageal cancer

          -  No other concurrent investigational agents