Phase II Trial of FOLFOX in Combination With Cetuximab and Concomitant Radiotherapy in the Treatment of Esophageal Cancer Stage III
18 Years
80 Years
Both
Esophageal Cancer Stage III
Trial Information
Phase II Trial of FOLFOX in Combination With Cetuximab and Concomitant Radiotherapy in the Treatment of Esophageal Cancer Stage III
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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)
Outcome Time Frame:
at 12 weeks and within 2 to 4 weeks following the end of additionnal treatment
Safety Issue:
Yes
Principal Investigator
Gérard LLEDO, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Assistance Publique - Hôpitaux de Paris
Authority:
France: Ministry of Health
Study ID:
P060503
NCT ID:
NCT00578201
Start Date:
November 2007
Completion Date:
February 2011
Related Keywords:
- Esophageal Cancer Stage III
- Esophageal neoplasms
- Cetuximab
- Oxaliplatin
- Fluorouracil
- radiotherapy
- Esophageal Diseases
- Esophageal Neoplasms
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