Fluorouracil, Cisplatin, Cetuximab, and Radiation Therapy in Treating Patients With Esophageal Cancer That Can Be Removed by Surgery

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving fluorouracil and cisplatin together with cetuximab and radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of fluorouracil and cisplatin when given together with cetuximab and radiation therapy in treating patients with esophageal cancer that can be removed by surgery.

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

Details

• Lead Sponsor: Federation Francophone de Cancerologie Digestive
• Treatments: Cetuximab; Cisplatin; Fluorouracil

Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

• Histologically confirmed epidermoid or glandular carcinoma of the thoracic esophagus

• Invasive disease

• Only Siewert type I gastroesophageal carcinoma allowed

• Resectable disease

• T1N+, T2N0, T2N+, T3N0, or T3N+ (stage II or III)

• No visceral metastases or mediastinal extensions compromising resectability

Exclusion criteria:

• Inoperable disease

• Invasion of the tracheo-bronchial tree

• Recurring esophageal paralysis

• Esopho-tracheal fistula

• Cervical esophageal carcinoma (< 19 cm above the dental arches)

• Multifocal esophageal carcinoma

• Superficial esophageal carcinoma (T1N0)

• Esophageal carcinoma in the lymph nodes that cannot be included in the radiotherapy field or cannot be completely surgically resected

• Proven metastatic disease

PATIENT CHARACTERISTICS:

Inclusion criteria:

• WHO performance status 0-1

• Weight loss < 15%

• Absolute neutrophil count ≥ 1,500/mm3

• Platelet count ≥ 100,000/mm3

• Creatinine ≤ 1.25 times upper limit of normal

• PTT ≥ 80%

• Albumin ≥ 35 g/L

• FEV1 > 1 L

• Not pregnant or nursing

• Fertile patients of must use effective contraception

Exclusion criteria:

• Known liver cirrhosis

• Renal insufficiency

• Respiratory insufficiency (i.e., severe dyspnea at rest or oxygen dependence)

• Progressive coronary insufficiency

• Myocardial infarction in the past 6 months

• Legally incapacitated

• Impossible to receive study therapy due to geographical, social, or psychological reasons

• Noncompliant within constraints of the study

• Hematologic malignancy or other cancer except carcinoma in situ of the uterine cervix, treated nonmelanoma skin cancer, or intramucous disease treated within the past 3 years

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

• Prior anticancer chemotherapy or radiotherapy

• Treatment with endoprosthesis

• Surgery (esophagectomy) planned without thoracotomy