Oxaliplatin, Capecitabine, and Radiation Therapy in Patients Undergoing Surgery for Stage II, III, IV Esophageal Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: National Comprehensive Cancer Network
• Treatments: Capecitabine; Oxaliplatin

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