Ganitumab and Gemcitabine Hydrochloride Followed by Radiation Therapy, Ganitumab, Capecitabine, and Maintenance Therapy in Treating Patients With Locally Advanced Cancer of the Pancreas
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |