This study is now complete.
In a clinical trial, researchers are combining commonly used pancreatic cancer chemotherapy with an immunotherapy drug approved for use in ovarian cancer, an antiretroviral drug used to treat HIV, and focused radiation to test the effectiveness of this combination before surgery to remove pancreatic cancer.
Testing Drugs in Combination
Gemcitabine is converted into two metabolites that cause cell death. One reduces the number of molecules available to make DNA; the other shortens the DNA strands. Fluorouracil (5-FU) disrupts a specific part of the cell replication cycle. Because both gemcitabine and 5-FU target all cells, not just cancer cells, they cause uncomfortable side effects. Leucovorin is derived from folic acid and enhances the effects of 5-FU.
Many pancreatic cancers develop from the epithelial cells in the pancreas. The tumor marker CA 125 is shed by epithelial cancer cells. Oregovomab is a monoclonal antibody that targets CA 125, eliciting an immune response. Nelfinavir, an antiretroviral drug used to treat HIV, has shown the ability to inhibit cancer growth in the laboratory.
Stereotactic body radiation therapy (SBRT) uses multiple beams of high-dose radiation focused on a specified location in the body. The technique enables the radiation oncologist to kill cancer cells and limit the exposure of healthy tissue to radiation. The precise location for the radiation beams is determined using 4-D imaging to map the area that will receive treatment. Metal markers are then implanted to outline the boundaries of that area.
A Complex Trial
Participants in this trial will start with gemcitabine, fluorouracil, and leucovorin. Patients with high CA 125 levels will receive oregovomab. As the trial progresses, nelfinavir will be added until just before SBRT. After the radiation treatment, nelfinavir will be added back to the drug combination . At the end of the treatments, patients whose tumors have shrunk will undergo surgery.
We encourage you to consult your physicians for clinical trials that may be right for you. The website ClinicalTrials.gov provides more details about this trial as well as many others. You can visit the EmergingMed Trial Finder for a listing of all active pancreatic cancer clinical trials.