Status:
COMPLETED
Combination Chemotherapy, Radiation Therapy and Surgery for Esophageal Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Adenocarcinoma of Esophagus
Squamous Cell Carcinoma of Esophagus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out what effects (good and bad) the combination of three chemotherapy drugs (cetuximab, cisplatin, and irinotecan) have on esophageal cancer when given with radiat...
Detailed Description
* Patients participating in this study must have a tumor biopsy taken to confirm the type of tumor. * Outpatient therapy with cetuximab alone will be given intravenously on week 0. * During week 1-8 o...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Negative pregnancy test
- Adenocarcinoma or squamous cell carcinoma of the esophagus, including the gastroesophageal junction, histologically confirmed, stage IIA, IIB and III.
- ECOG performance status of 0 or 1.
- Neutrophils greater or equal to 1,500/ul
- Platelets greater or equal to 100,000/ul
- Serum bilirubin less or equal to 1.5mg/ul
- Serum creatinine less or equal to 1.5mg/ul
- AST or SGOT less or equal to 2.5x upper normal limit
- Alkaline phosphatase less or equal to 5x upper normal limit
Exclusion
- Prior surgery for esophageal or gastro-esophageal junction cancer.
- Prior chemotherapy or radiation therapy
- Biopsy proven tumor invasion of the tracheobronchial tree or tracheo-esophageal fistula.
- Metastatic disease to distant organs or non-regional lymph nodes.
- Co-morbid disease that in the opinion of the investigator makes combined chemo-radiotherapy inadvisable.
- Pregnant or lactating women
- Other active malignancy
- Patients with known Gilbert's Disease or interstitial pulmonary fibrosis.
- History of seizure disorder
- Uncontrolled diarrhea
- Peripheral neuropathy (Grade 2)
- Prior cetuximab or other therapy that specifically and directly targets the EGF pathway.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00165490
Start Date
August 1 2004
End Date
November 1 2014
Last Update
November 10 2014
Active Locations (2)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115