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

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ClinicalTrials.gov Identifier: NCT00544362
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : May 30, 2016
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Esophageal Cancer Biological: cetuximab Drug: cisplatin Drug: fluorouracil Procedure: conventional surgery Phase 1 Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Neoadjuvant chemoradiotherapy
Weekly cetuximab (400 mg/m2 one week before start of radiotherapy RT and 250 mg/m2 during radiotherapyRT), and 5 FU (500 mg/m2 per day D1-D4) combined with cisplatin CDDP (40 mg/m2 D1) on week 1 and 5
 Biological: cetuximab
Drug: cisplatin
Drug: fluorouracil
Procedure: conventional surgery


Outcome Measures
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Primary Outcome Measures :
  1. Complete histologic response [ Time Frame: After Surgery ]
  2. Tolerance to neoadjuvant therapy [ Time Frame: From Inclusion ]

Secondary Outcome Measures :
  1. Progression-free and overall survival [ Time Frame: From inclusion ]
  2. Mortality [ Time Frame: From Inclusion ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544362


Locations
France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besancon, France, 25030
Hopital Saint Andre
Bordeaux, France, 33075
C.H.U. de Brest
Brest, France, 29200
CHR Clermont Ferrand, Hotel Dieu
Clermont-Ferrand, France, 63058
Hopital Du Bocage
Dijon, France, 21034
Federation Francophone de Cancerologie Digestive
Dijon, France, 21079
Centre Oscar Lambret
Lille, France, 59020
Centre Hospital Universitaire Hop Huriez
Lille, France, 59037
CHU de la Timone
Marseille, France, 13385
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Centre Hospitalier Regional de Purpan
Toulouse, France, 31059
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
Study Chair: Martina Schneider Federation Francophone de Cancerologie Digestive
More Information
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Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT00544362     History of Changes
Other Study ID Numbers: CDR0000564075
FFCD-0505
EU-20756
EUDRACT-2006-004770-27
MERCK-FFCD-0505
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: May 30, 2016
Last Verified: May 2016

Keywords provided by Federation Francophone de Cancerologie Digestive:
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
Cisplatin
 Cetuximab
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs