FOLFOX-Cetuximab-Radiotherapy for the Treatment of Esophageal Cancer - Full Text View

Sponsors and Collaborators:	Assistance Publique - Hôpitaux de Paris Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00578201

Purpose

This phase II trial is studying the effects of oxaliplatin, leucovorin and fluorouracil-when given together with Cetuximab and radiation therapy and radiation therapy to see how they work in treating patients with stage III esophageal cancer.

Condition	Intervention	Phase
Stage III Esophageal Cancer	Drug: radiochemotherapy,combination Cetuximab-FOLFOX	Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Fluorouracil Oxaliplatin Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial of FOLFOX in Combination With Cetuximab and Concomitant Radiotherapy in the Treatment of Esophageal Cancer Stage III

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

objective response rate (ORR) at 12 weeks with radiochemotherapy (first evaluation), and if applicable, within 2 to 4 weeks following the end of additional treatment with the combination Cetuximab-FOLFOX (second evaluation) [ Time Frame: at 12 weeks and within 2 to 4 weeks following the end of additionnal treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Progression free survival Quality of life Dysphagia score Overall survival toxicity of this regimen [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental radiochemotherapy,combination Cetuximab-FOLFOX	Drug: radiochemotherapy,combination Cetuximab-FOLFOX objective response rate at 12 weeks with radiochemotherapy then combination Cetuximab-FOLFOX

Detailed Description:

Cetuximab is a monoclonal antibody which can block the ability of tumor cells to grow and spread Cetuximab may also make tumor cells more sensitive to radiation therapy. Drug used in chemotherapy such as oxaliplatin leucovorin and Fluorouracil work in different way to stop the growth of tumor cells either by killing the cells or by stopping them form dividing. Radiation therapy uses high energy X rays to kill tumor cells. Giving cetuximab could improve the efficacy of chemotherapy and radiation therapy and may make the tumor smaller This phase II trial is studying the effects of oxaliplatin, leucovorin and fluorouracil-when given together with Cetuximab and radiation therapy and radiation therapy to see how they work in treating patients with stage III esophageal cancer.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed squamous cell carcinoma of the esophagus stage III (according to UICC classification)
Measurable disease according to the RECIST criteria
WHO performance status of 0 or 1
Age 18-80 years old
Reference imaging within the 2 weeks prior to the treatment
Hematological and biochemical assessment within the 2 weeks prior to the treatment
Neutrophils >1.5 10 9/L, platelets >150.10 9/L, Haemoglobin ≥10g/dL, Bilirubin ≤ 1.25 ULN, Aspartate Aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 ULN Woman of childbearing potential must use effective contraception methods Written informed consent obtained No prior chemotherapy or radiation therapy for esophageal cancer

Exclusion Criteria:

Stage I, II or IV (according to UICC classification)
Esophageal carcinoma with small cells or endocrine cells or esophageal stromal tumor
visceral metastasis
orotracheal fistula weight loss >15% within the previous 6 months Pregnancy or breast feeding Contra indication to the study treatment History of coronary heart disease uncontrolled, or myocardial necrosis within the previous 6 months
Peripheral Neuropathy NCI >1
Liver Failure
Prior thoracic radiation therapy
history of cancer within the previous 5 years (except removed skin carcinoma, removed local melanoma located, and carcinoma cervix of uterus Esophageal Endoprosthesis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578201

Contacts

Contact: Gérard LLEDO, MD

+33(0)4 78 78 10 51

lledogerard@aol.com

Locations

France
Clinique Saint Jean	Recruiting
LYON, France, 69008
Contact: Gérard LLEDO

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Investigators

Principal Investigator:

Gérard LLEDO, MD

Assistance Publique - Hôpitaux de Paris

More Information

Responsible Party:	Departement clinical research of the developpement ( Isabelle BRINDEL )
Study ID Numbers:	P060503, ERaFOX-GERCOR D06-1
Study First Received:	December 20, 2007
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00578201
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Esophageal neoplasms
Cetuximab
Oxaliplatin
Fluorouracil
radiotherapy

Study placed in the following topic categories:

Oxaliplatin
Digestive System Neoplasms
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases
Fluorouracil

Head and Neck Neoplasms
Esophageal Neoplasms
Cetuximab
Gastrointestinal Neoplasms
Esophageal Diseases
Esophageal neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009