Combination Chemotherapy, Radiation Therapy and Surgery for Esophageal Cancer

Completed · Phase 2

Conditions studied: Adenocarcinoma of Esophagus, Squamous Cell Carcinoma of Esophagus

In brief

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.

Key facts

Study ID

NCT00165490

Run by

Dana-Farber Cancer Institute

People needed

19

Starts

2004-08-01

Expected to finish

2014-11-01

Last updated by the study team

2014-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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