Status:
UNKNOWN
Cetuximab, Oxaliplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Stage II or Stage III Esophageal Cancer
Lead Sponsor:
Technical University of Munich
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 maximum tolerated dose of oxaliplatin and fluorouracil when administered with cetuximab and radiotherapy in patients with stage II or III squamous cell carcinoma ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the esophagus, meeting the following criteria:
- Locally advanced disease (T3-T4, N0-N+ \[T2, N0 for cervical esophageal carcinoma\])
- Potentially resectable disease
- No distant metastases (M1b)
- No tumor infiltration of the tracheobronchial system
- Bartels preoperative risk analysis \< 22
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance \> 60 mL/min
- Bilirubin ≤ 1.5 mg/dL
- ALT and AST ≤ 2 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2 times ULN
- WBC ≥ 3,000/mm³
- Granulocyte count ≥ 2,000/mm³
- Platelet count ≥ 100,000/mm³
- No pre-existing polyneuropathy \> grade 1
- No active uncontrolled infection
- PaO\_2 ≥ 60 mm Hg on room air
- FEV\_1 ≥ 60% of normal
- No New York Heart Association class II-IV cardiac insufficiency
- Ejection fraction ≥ 35%
- No angina pectoris (at rest or under stress) unexplained by interventional cardiology
- No myocardial infarction within the past 6 months
- No histologically confirmed liver cirrhosis
- No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanomatous skin cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- No prior radiotherapy to the thorax region
- No current esophageal stent
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2015
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00425425
Start Date
July 1 2006
End Date
May 1 2015
Last Update
May 1 2014
Active Locations (3)
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1
Charite University Hospital - Campus Virchow Klinikum
Berlin, Germany, D-13353
2
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
Marburg, Germany, D-35033
3
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, Germany, D-81675