drugset / Trial / NCT01068327

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

NCT01068327

NaSingle-groupOpen-labelTreatment

Summary

This phase I trial is studying the side effects and best dose of stereotactic radiation therapy and nelfinavir mesylate when given together with gemcitabine hydrochloride, leucovorin calcium, and fluorouracil in treating patients with locally advanced pancreatic cancer. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs, such as nelfinavir mesylate, may make tumor cells more sensitive to radiation therapy. 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 or by stopping them from dividing. Giving stereotactic radiation therapy and nelfinavir mesylate together with combination chemotherapy may kill more tumor cells.

Timeline

Start
2007-11-05
Primary completion
2013-08-01
Completion
2015-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Nelfinavir Other / unclassified 625 mg Oral
Subject Nelfinavir Other / unclassified 1250 mg Oral
Background Gemcitabine Small molecule Intravenous
Background Leucovorin Small molecule Intravenous
Background fluorouracil Small molecule Intravenous