Status:
COMPLETED
Cetuximab, Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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 c...
Detailed Description
OBJECTIVES: Primary * Determine the safety of neoadjuvant radiotherapy in combination with cetuximab, docetaxel, and cisplatin in patients with resectable locally advanced esophageal cancer. Second...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus
- Carcinoma of the gastroesophageal junction (i.e., Siewert staging system type I disease) allowed
- Locally advanced disease
- Obstructive tumors are considered locally advanced disease
- Meets 1 of the following staging criteria:
- T3, N0 disease
- T1-3, N1 disease
- T4, N0-1 disease
- Resectable disease
- No T4 (unequivocal organ involvement) disease that cannot be resected with curative intent
- 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:
- New York Heart Association class III or IV congestive heart failure
- Unstable angina pectoris
- Myocardial infarction within the past 3 months
- Significant arrhythmias
- 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:
- No prior chemotherapy
- No prior radiotherapy to the chest
- No participation in another clinical trial within the past 30 days
- No other concurrent experimental drugs or anticancer therapy
- No concurrent drugs contraindicated for use with the study drugs
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00445861
Start Date
January 1 2007
End Date
November 1 2008
Last Update
June 11 2012
Active Locations (2)
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1
Kantonsspital - St. Gallen
Sankt Gallen, Switzerland, CH-9007
2
Klinik Stephanshorn
Sankt Gallen, Switzerland, Ch-9016