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

Phase 1

Completed

• Conditions: Esophageal Cancer
• Interventions: Biological: cetuximab; Drug: cisplatin; Drug: fluorouracil; Procedure: conventional surgery

• Registration Number: NCT00544362
• Lead Sponsor: Federation Francophone de Cancerologie Digestive

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-10-13
• Study First Submitted QC: 2007-10-13
• Study First Posted: 2007-10-16
• Primary Completion: 2011-01
• Study Completion: 2013-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-27
• Last Update Posted: 2016-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant chemoradiotherapy	cetuximab	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
Neoadjuvant chemoradiotherapy	cisplatin	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
Neoadjuvant chemoradiotherapy	fluorouracil	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
Neoadjuvant chemoradiotherapy	conventional surgery	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

Primary Outcome Measures

Name	Time	Method
Complete histologic response	After Surgery
Tolerance to neoadjuvant therapy	From Inclusion

Secondary Outcome Measures

Name	Time	Method
Progression-free and overall survival	From inclusion
Mortality	From Inclusion

Trial Locations

Locations (13)

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz; 🇫🇷 Besancon, France

Centre Hospitalier Regional de Purpan; 🇫🇷 Toulouse, France

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre-les-Nancy, France

C.H.U. de Brest; 🇫🇷 Brest, France

Centre Hospital Universitaire Hop Huriez; 🇫🇷 Lille, France

Hopital Saint Andre; 🇫🇷 Bordeaux, France

CHR Clermont Ferrand, Hotel Dieu; 🇫🇷 Clermont-Ferrand, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Hopital Du Bocage; 🇫🇷 Dijon, France

Federation Francophone de Cancerologie Digestive; 🇫🇷 Dijon, France

CHU de la Timone; 🇫🇷 Marseille, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Benite, France

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France