Fluorouracil, Cisplatin, Cetuximab, and Radiation Therapy in Treating Patients With Esophageal Cancer That Can Be Removed by Surgery
Conditions
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage IIIA esophageal cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer, stage IV esophageal cancer
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: cetuximab Type: Biological
Name: cisplatin Type: Drug
Name: fluorouracil Type: Drug
Name: conventional surgery Type: Procedure
Name: neoadjuvant therapy Type: Procedure
Overall Status
Recruiting
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.
Detailed Description
OBJECTIVES:

Primary

- To determine the maximum tolerated dose of fluorouracil and cisplatin when administered with cetuximab concurrently with esophageal radiotherapy. (Phase I)

- To determine the complete histological response rate (after surgical resection). (Phase II)

Secondary

- To determine progression-free survival and overall survival. (Phase II)

- To determine the rate of resection with negative margins (R0). (Phase II)

- To determine the overall tolerance to neoadjuvant therapy. (Phase II)

- To determine the postoperative morbidity and mortality. (Phase II)

OUTLINE: This is a multicenter study. This is a dose-escalation study of cisplatin and fluorouracil.

Patients receive cetuximab IV over 2 hours on day -7, then IV over 1 hour on days 1, 8, 15, 22, and 29. Patients also receive cisplatin IV over 1 hour on day 1 or 2 and fluorouracil IV continuously on days 1-4, 8-11, 15-18, 22-25, and 29-32. Patients undergo radiotherapy 5 days a week for 5 weeks, beginning on day 1 of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients undergo surgery within 6-8 weeks after completion of chemoradiotherapy.

After completion of study therapy, patients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 2 years.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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
Locations
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besancon, France
Status: Recruiting
Contact: Thanh Van N'Guyen - 33-81-668-240
Hopital Saint Andre
Bordeaux, France
Status: Recruiting
Contact: Veronique Vendrely - 33-5-5679-5808
C.H.U. de Brest
Brest, France
Status: Recruiting
Contact: Jean-Philippe Metges, MD - 33-2-9822-3333
CHR Clermont Ferrand, Hotel Dieu
Clermont-Ferrand, France
Status: Recruiting
Contact: Denis Pezet, MD - 33-73-750-494 - dpezet@chu-clermontferrand.fr
Federation Francophone de Cancerologie Digestive
Dijon, France
Status: Recruiting
Contact: Martina Schneider - 33-3-8039-3483
Hopital Du Bocage
Dijon, France
Status: Recruiting
Contact: Jean-Louis Jouve - 33-3-8029-3750 - jean-louis.jouve@chu-dijon.fr
Centre Hospital Universitaire Hop Huriez
Lille, France
Status: Recruiting
Contact: Christophe Mariette, MD, PhD - 33-32-44-4407 - c-mariette@chru-lille.fr
Centre Oscar Lambret
Lille, France
Status: Recruiting
Contact: Antoine Adenis, MD, PhD - 33-320-29-59-42 - a-adenis@o-lambret.fr
CHU de la Timone
Marseille, France
Status: Recruiting
Contact: Jean-Francois Seitz, MD - 33-4-9138-6023
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France
Status: Recruiting
Contact: Marc Ychou, MD, PhD - 33-4-6761-3066 - mychou@valdorel.fnclcc.fr
Centre Hospitalier Lyon Sud
Pierre Benite, France
Status: Recruiting
Contact: Francoise Mornex, MD, PhD - 33-478-864-253 - francoise.mornex@chu-lyon.fr
Centre Hospitalier Regional de Purpan
Toulouse, France
Status: Recruiting
Contact: Nicolas Carrere, MD, PhD - 33-56-177-7610 - carrere.n@chu-toulouse.fr
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France
Status: Recruiting
Contact: Thierry Conroy, MD - 33-3-8359-8460
Start Date
July 2007
Sponsors
Federation Francophone de Cancerologie Digestive
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page