drugset / Trial / NCT01142388

Paclitaxel With or Without Cixutumumab as Second-Line Therapy in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer

NCT01142388

Phase 2 Active not recruiting 94 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II trial studies how well paclitaxel with or without cixutumumab works in treating patients with esophageal cancer or gastroesophageal junction cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cixutumumab may kill cancer cells by blocking the action of a protein needed for cancer cell growth. Giving paclitaxel with or without cixutumumab may kill more tumor cells.

Timeline

Start
2010-09-21
Primary completion
2014-07-15
Completion
2027-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cixutumumab Monoclonal antibody 10 mg/kg Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous