drugset / Trial / NCT00551759

Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer

NCT00551759 ↗

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and docetaxel, 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. 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. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving docetaxel and cetuximab after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving chemotherapy and radiation therapy together with cetuximab followed by surgery, docetaxel and cetuximab works in treating patients with esophageal cancer or gastroesophageal junction cancer.

Timeline

Start
2008-10-02
Primary completion
2011-10
Completion
2014-02

Outcome

Outcome not reported

Stopped: “The study used a two-stage design. After stage one, the study was terminated due to excess toxicity.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody — Intravenous
Subject Docetaxel Small molecule — Intravenous
Subject Oxaliplatin Small molecule — Intravenous
Subject fluorouracil Small molecule — Intravenous

Indications