Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer

• Status: Completed
• Trial end date: 2013-01-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Treatments: Capecitabine; Oxaliplatin

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