drugset / Trial / NCT01298401

Ganitumab and Gemcitabine Hydrochloride Followed by Radiation Therapy, Ganitumab, Capecitabine, and Maintenance Therapy in Treating Patients With Locally Advanced Cancer of the Pancreas

NCT01298401

Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Monoclonal antibodies, such as ganitumab, 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 cancer-killing substances to them. Drugs used in chemotherapy, such as gemcitabine hydrochloride and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a high-dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of ganitumab when given together with gemcitabine hydrochloride followed by radiation therapy, ganitumab, capecitabine, and maintenance therapy in treating patients with locally advanced cancer of the pancreas.

Timeline

Start
2012-02
Primary completion
2013-11
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 625 mg/m2 Oral
Subject Capecitabine Small molecule 825 mg/m2 Oral
Subject Ganitumab Monoclonal antibody 6 mg/kg Intravenous
Subject Ganitumab Monoclonal antibody 12 mg/kg Intravenous
Subject Ganitumab Monoclonal antibody 20 mg/kg Intravenous
Subject Gemcitabine Small molecule Intravenous