FOLFOX-Cetuximab-radiotherapy for the Treatment of Esophageal Cancer

This study has been completed.
Sponsor:
Collaborator:
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00578201
First received: December 20, 2007
Last updated: March 30, 2011
Last verified: May 2007
  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
Esophageal Cancer Stage III
Drug: radiochemotherapy,combination Cetuximab-FOLFOX
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of FOLFOX in Combination With Cetuximab and Concomitant Radiotherapy in the Treatment of Esophageal Cancer Stage III

Resource links provided by NLM:


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 ]

Enrollment: 80
Study Start Date: November 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
radiochemotherapy,combination Cetuximab-FOLFOX
Drug: radiochemotherapy,combination Cetuximab-FOLFOX
objective response rate at 12 weeks with radiochemotherapy then combination Cetuximab-FOLFOX
Other Name: objective response rate,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
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: NCT00578201

Locations
France
Clinique Saint Jean
Lyon, France, 69008
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

No publications provided

Responsible Party: Isabelle BRINDEL, Departement clinical research of the developpement
ClinicalTrials.gov Identifier: NCT00578201     History of Changes
Other Study ID Numbers: P060503
Study First Received: December 20, 2007
Last Updated: March 30, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Esophageal neoplasms
Cetuximab
Oxaliplatin
Fluorouracil
radiotherapy

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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014