drugset / Trial / NCT00425425

Cetuximab, Oxaliplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Stage II or Stage III Esophageal Cancer

NCT00425425

Phase 1/2 Unknown 43 enrolled Technical University of Munich
Open-labelTreatment

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 carry tumor-killing substances to them. Cetuximab may also make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab, chemotherapy, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase I/II trial is studying the side effects and best dose of oxaliplatin and fluorouracil when given together with cetuximab and radiation therapy and to see how well they work in treating patients with stage II or stage III esophageal cancer.

Timeline

Start
2006-07
Primary completion
2010-05
Completion
2015-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxaliplatin Small molecule Intravenous
Subject fluorouracil Small molecule Intravenous
Background Cetuximab Monoclonal antibody Intravenous

Indications