FOLFOX-Cetuximab-radiotherapy for the Treatment of Esophageal Cancer

Esophageal Cancer Stage III Clinical Trial

— FOLFOX  

Official title:

Phase II Trial of FOLFOX in Combination With Cetuximab and Concomitant Radiotherapy in the Treatment of Esophageal Cancer Stage III

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00578201
• Other study ID #: P060503
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2007
• Last updated: March 30, 2011
• Start date: November 2007
• Est. completion date: February 2011

Study information

• Verified date: May 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer Stage III
• Esophageal Neoplasms

Intervention

Drug:
• radiochemotherapy,combination Cetuximab-FOLFOX
objective response rate at 12 weeks with radiochemotherapy then combination Cetuximab-FOLFOX

Locations

Country	Name	City	State
France	Clinique Saint Jean	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		at 12 weeks and within 2 to 4 weeks following the end of additionnal treatment	Yes
Secondary	Progression free survival Quality of life Dysphagia score Overall survival toxicity of this regimen		during the study	Yes