Name of Protocol

Combination Chemotherapy With or Without Oregovomab Followed by Stereotactic Body Radiation Therapy and Nelfinavir Mesylate in Treating Patients With Locally Advanced Pancreatic Cancer

Purpose

CA-125 levels are not only elevated in ovarian cancer, but also in pancreatic cancer as well. The purpose of this 66-patient open label Phase 2 trial is to evaluate the efficacy of neoadjuvant chemotherapy, (gemcitabine [gemcitabine hydrochloride], leucovorin [leucovorin calcium], fluorouracil [5-FU]) with or without oregovomab, followed by hypo fractionated stereotactic radiotherapy (SRT) concurrently with nelfinavir (nelfinavir mesylate) in patients with locally advanced pancreatic cancer that is CA-125 positive (>= 10U/ml) or CA-125 negative (< 10U/ml).

Additional endpoints being studied are safety, and cellular and humoral immune responses to active immunotherapy with oregovomab in patients with pancreas cancer with CA-125 level greater than 10U/ml undergoing chemotherapy and radiation treatments.

Timeline

This study has completed enrollment. Patients are followed up every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter. The study is expected to be completed in December 2018.

Participating Centers

Dr. Chi Lin