Combination Chemotherapy, Radiation Therapy and Surgery for Esophageal Cancer

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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 radiation therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: Brigham and Women's Hospital
• Treatments: Cetuximab; Cisplatin; Irinotecan

Criteria

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.