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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00544362
First received: October 13, 2007
Last updated: December 3, 2011
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Biological: cetuximab
Drug: cisplatin
Drug: fluorouracil
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant Treatment for Operable Esophageal Cancer With 5-fluorouracil, Cisplatin, and Cetuximab and Concurrent Radiotherapy: Phase I/II Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Complete histologic response [ Designated as safety issue: No ]
  • Tolerance to neoadjuvant therapy [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free and overall survival [ Designated as safety issue: No ]
  • Complete resection with negative margins (R0) [ Designated as safety issue: No ]
  • Mortality [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544362

Locations
France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz Recruiting
Besancon, France, 25030
Contact: Thanh Van N'Guyen    33-81-668-240      
Hopital Saint Andre Recruiting
Bordeaux, France, 33075
Contact: Veronique Vendrely    33-5-5679-5808      
C.H.U. de Brest Recruiting
Brest, France, 29200
Contact: Jean-Philippe Metges, MD    33-2-9822-3333      
CHR Clermont Ferrand, Hotel Dieu Recruiting
Clermont-Ferrand, France, 63058
Contact: Denis Pezet, MD    33-73-750-494    dpezet@chu-clermontferrand.fr   
Hopital Du Bocage Recruiting
Dijon, France, 21034
Contact: Jean-Louis Jouve    33-3-8029-3750    jean-louis.jouve@chu-dijon.fr   
Federation Francophone de Cancerologie Digestive Recruiting
Dijon, France, 21079
Contact: Martina Schneider    33-3-8039-3483      
Centre Hospital Universitaire Hop Huriez Recruiting
Lille, France, 59037
Contact: Christophe Mariette, MD, PhD    33-32-44-4407    c-mariette@chru-lille.fr   
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Antoine Adenis, MD, PhD    33-320-29-59-42    a-adenis@o-lambret.fr   
CHU de la Timone Recruiting
Marseille, France, 13385
Contact: Jean-Francois Seitz, MD    33-4-9138-6023      
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Marc Ychou, MD, PhD    33-4-6761-3066    mychou@valdorel.fnclcc.fr   
Centre Hospitalier Lyon Sud Recruiting
Pierre Benite, France, 69495
Contact: Francoise Mornex, MD, PhD    33-478-864-253    francoise.mornex@chu-lyon.fr   
Centre Hospitalier Regional de Purpan Recruiting
Toulouse, France, 31059
Contact: Nicolas Carrere, MD, PhD    33-56-177-7610    carrere.n@chu-toulouse.fr   
Centre Alexis Vautrin Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: Thierry Conroy, MD    33-3-8359-8460      
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
Study Chair: Martina Schneider Federation Francophone de Cancerologie Digestive
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00544362     History of Changes
Other Study ID Numbers: CDR0000564075, FFCD-0505, EU-20756, EUDRACT-2006-004770-27, MERCK-FFCD-0505
Study First Received: October 13, 2007
Last Updated: December 3, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cetuximab
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014