drugset / Trial / NCT01959672

Chemotherapy, Stereotactic Body Radiation Therapy & Nelfinavir Mesylate in Locally Advanced Pancreatic Cancer

NCT01959672

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies how well combination chemotherapy with or without oregovomab followed by stereotactic body radiation therapy (SBRT) and nelfinavir mesylate works in treating patients with pancreatic cancer that has spread to nearby organs or tissues. Drugs used in chemotherapy, such as gemcitabine hydrochloride, leucovorin calcium, and fluorouracil, 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. Monoclonal antibodies, such as oregovomab, can block tumor growth in different ways by targeting certain cells. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Drugs, such as nelfinavir mesylate, may make tumor cells more sensitive to radiation therapy. Giving combination chemotherapy with or without oregovomab followed by SBRT and nelfinavir mesylate may kill more tumor cells.

Timeline

Start
2013-09-06
Primary completion
2018-04-01
Completion
2018-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule Intravenous
Subject Leucovorin Small molecule Intravenous
Subject Nelfinavir Other / unclassified Oral
Subject Oregovomab Monoclonal antibody Intravenous
Subject fluorouracil Small molecule Intravenous