Combination Chemotherapy, Radiation Therapy and Surgery for Esophageal Cancer
Combination Chemotherapy, Radiation Therapy and Surgery for Esophageal Cancer
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 radiation therapy.
-  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 outpatient radiation therapy will be started and continued once per day
 for 28 treatments or 5 1/2 weeks.

 -  Outpatient chemotherapy (cisplatin, irinotecan and cetuximab) is given once per week on
 weeks 1, 2, 4, and 5. Cetuximab alone will be given on weeks 3, 6, 7, and 8.

 -  A repeat CT scan and PET scan will be performed to restage the tumor on week 8. This is
 to confirm that the cancer has remained localized.

 -  Inpatient surgery is scheduled 4 to 8 weeks after completion of chemotherapy and
 radiation therapy.

 -  Cetuximab will be restarted within 4 weeks after surgery and continue weekly for 6
 months.

 -  During chemotherapy and radiation therapy, physical exams and vital signs will be
 performed before each chemotherapy treatment. Routine blood tests will also be
 performed.

 -  Between chemotherapy-radiation therapy and surgery a CAT scan of chest, abdomen and
 pelvis along with a PET scan will be performed.

 -  After surgery a CAT scan of chest, abdomen and pelvis will be performed every 3 months
 for 2 years then every 6 months for 3 years. An EGD (upper endoscopy) with biopsy will
 be done every 6 months for 2 years and then yearly for 3 years. Physical exam, vital
 signs and routine blood tests will be done every 2 weeks for 6 months, then every 3
 months for 1.5 years, and then every 6 months for 3 years.
Inclusion Criteria:

 -  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 Criteria:

 -  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.