Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: Induction Therapy - Capecitabine; Induction Therapy - Oxaliplatin; Combination Therapy - Capecitabine; Combination Therapy - Oxaliplatin; Combination Therapy - Radiation; Evaluation for response and surgery
Intervention description: Two 21-day cycles will be given as induction. Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.; Two 21-day cycles will be given as induction. Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over two hours on days 1 and 8 of each cycle.; Two 21-day cycles will be given for combination therapy. Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.; Two 21-day cycles will be given. Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.; 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.; Four to eight weeks following the completion of therapy subjects will undergo evaluation for response and surgical resection.
Intervention MeSH terms: Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the esophagus; stage I esophageal cancer; stage II esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, 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 and 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 capecitabine and oxaliplatin
      together with radiation therapy works in treating patients with esophageal or
      gastroesophageal junction cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed adenocarcinoma of the esophagus or
             gastroesophageal junction

               -  Stage I-IVA disease

          -  No distant metastatic disease (other than regional lymph nodes)

          -  No evidence of CNS metastases

               -  CNS metastases stable for > 3 months allowed

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Consuming ≥ 1,500 calories daily

          -  ANC ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  SGOT ≤ 2.5 times ULN

          -  Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No pre-existing neuropathy

          -  No prior unanticipated severe reaction to fluoropyrimidine therapy

          -  No known hypersensitivity to fluorouracil

          -  No known DPD deficiency

          -  No known hypersensitivity to any of the components of oxaliplatin

          -  No significant active infection or other severe complicated medical illness

          -  No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic
             coronary artery disease, or cardiac arrhythmias not well controlled with medication)

          -  No myocardial infarction within the past 12 months

          -  No history of uncontrolled seizures, CNS disorders, or psychiatric disability judged
             by the investigator to be clinically significant, precluding informed consent, or
             interfering with compliance of oral drug intake

          -  No malabsorption syndrome

          -  No other active malignancy within the past 3 years except cervical carcinoma in situ
             or nonmelanoma skin cancer

        PRIOR CONCURRENT THERAPY:

          -  More than 4 weeks since prior participation in any investigational drug study

          -  No prior pelvic or thoracic radiotherapy