Cetuximab, Oxaliplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Stage II or Stage III Esophageal Cancer

• Status: Unknown status
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, 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 cetuximab, 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 I/II trial is studying the side effects and best dose of oxaliplatin and fluorouracil when given together with cetuximab and radiation therapy and to see how well they work in treating patients with stage II or stage III esophageal cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität München
• Treatments: Cetuximab; Fluorouracil; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the esophagus, meeting the following criteria:

• Locally advanced disease (T3-T4, N0-N+ [T2, N0 for cervical esophageal carcinoma])

• Potentially resectable disease

• No distant metastases (M1b)

• No tumor infiltration of the tracheobronchial system

• Bartels preoperative risk analysis < 22

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%

• Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 60 mL/min

• Bilirubin ≤ 1.5 mg/dL

• ALT and AST ≤ 2 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 2 times ULN

• WBC ≥ 3,000/mm³

• Granulocyte count ≥ 2,000/mm³

• Platelet count ≥ 100,000/mm³

• No pre-existing polyneuropathy > grade 1

• No active uncontrolled infection

• PaO_2 ≥ 60 mm Hg on room air

• FEV_1 ≥ 60% of normal

• No New York Heart Association class II-IV cardiac insufficiency

• Ejection fraction ≥ 35%

• No angina pectoris (at rest or under stress) unexplained by interventional cardiology

• No myocardial infarction within the past 6 months

• No histologically confirmed liver cirrhosis

• No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanomatous skin cancer

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy

• No prior radiotherapy to the thorax region

• No current esophageal stent