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

NCT00544362 | Completed Phase 1

• 5 other identifiers: CDR0000564075FFCD-0505EU-20756EUDRACT-2006-004770-27MERCK-FFCD-0505
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 13

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.

Conditions

Esophageal Cancer

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

Outcome Measures

Primary Outcomes (2)

• Complete histologic response

  After Surgery

• Tolerance to neoadjuvant therapy

  From Inclusion

Secondary Outcomes (2)

• Progression-free and overall survival

  From inclusion

• Mortality

  From Inclusion

Study Arms (1)

Neoadjuvant chemoradiotherapy

EXPERIMENTAL

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

Interventions

cetuximab BIOLOGICAL

Neoadjuvant chemoradiotherapy

cisplatin DRUG

Neoadjuvant chemoradiotherapy

fluorouracil DRUG

Neoadjuvant chemoradiotherapy

conventional surgery PROCEDURE

Neoadjuvant chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

Study Sites (13)

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Hopital Saint Andre

Bordeaux, 33075, France

Location

C.H.U. de Brest

Brest, 29200, France

Location

CHR Clermont Ferrand, Hotel Dieu

Clermont-Ferrand, 63058, France

Location

Hopital Du Bocage

Dijon, 21034, France

Location

Federation Francophone de Cancerologie Digestive

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Hospital Universitaire Hop Huriez

Lille, 59037, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Regional de Purpan

Toulouse, 31059, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma

Interventions

Cetuximab; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Martina Schneider

  Federation Francophone de Cancerologie Digestive

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2007
• First Posted: October 16, 2007
• Study Start: July 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: March 1, 2013
• Last Updated: May 30, 2016

Record last verified: 2016-05

Locations

FR (13)