Status and phase
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About
RATIONALE: 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. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab, docetaxel, and cisplatin together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase I/II trial is studying the side effects of cetuximab, docetaxel, cisplatin, and radiation therapy and to see how well they work in treating patients with locally advanced esophageal cancer that can be removed by surgery.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Chemoimmunotherapy: Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-3 and docetaxel IV over 1 hour and cisplatin IV over 1 hour once in week 1. Treatment repeats every 3 weeks for 2 courses.
Chemoimmunotherapy and radiotherapy: Patients are sequentially assigned to 1 of 2 treatment levels.
Cohorts of 7-20 patients are treated at treatment level 1 or 2 sequentially, as long as no more than 2 of 7 patients experience dose-limiting toxicity (DLT), until the safe treatment level for future study is determined. The safe treatment level is defined as the level at which no more than 2 of 7 and no more than 6 of 20 patients experience DLT. At least 20 patients are treated at the safe treatment level.
After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus
Locally advanced disease
Obstructive tumors are considered locally advanced disease
Meets 1 of the following staging criteria:
Resectable disease
No airway infiltration in case of tumors of the upper third of the thoracic esophagus
No cervical esophageal carcinoma
No distant metastasis, including stage M1a (celiac node involvement) by fine-needle aspiration or biopsy
PATIENT CHARACTERISTICS:
WHO performance status 0-1
Creatinine clearance > 60 mL/min
Bilirubin normal
Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
AST ≤ 1.5 times ULN
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 12 months after completion of study treatment
No other malignancy within the past 5 years except nonmelanomatous skin cancer or adequately treated in situ cervical cancer
No severe or uncontrolled cardiovascular disease including, but not limited to, any of the following:
No psychiatric disorder that would preclude study compliance
No active uncontrolled infection
No serious underlying medical condition that, in the opinion of the investigator, would interfere with study participation (e.g., uncontrolled diabetes mellitus or active autoimmune disease)
No peripheral neuropathy > grade 1
No contraindications to corticosteroids
No known hypersensitivity to any component of the study drugs
PRIOR CONCURRENT THERAPY:
Primary purpose
Allocation
Interventional model
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Data sourced from clinicaltrials.gov
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