A Pilot Study of Gemcitabine, Nab-Paclitaxel, PEGPH20, and Rivaroxaban for Advanced Pancreatic Cancer

Full Title

Pilot Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma

Purpose

Gemcitabine and nab-paclitaxel are chemotherapy drugs used to treat adenocarcinoma of the pancreas (pancreatic cancer). PEGPH20 is an investigational drug. It is an enzyme that breaks down hyaluronan, a substance found in high amounts in pancreatic cancers. A prior study of gemcitabine, nab-paclitaxel, and PEGPH20 showed that patients receiving this treatment had an increased risk of blood clots.

In this study, patients with advanced pancreatic cancer will receive gemcitabine, nab-paclitaxel, and PEGPH20 along with the drug rivaroxaban. This medication is used to reduce the risk of blood clots. It is a pill that is taken orally (by mouth); gemcitabine, nab-paclitaxel, and PEGPH20 are given intravenously (by vein). Researchers hope that the three anticancer drugs will shrink pancreatic tumors and that the addition of rivaroxaban (evaluated here at two different doses) will lower the chance of developing a blood clot during treatment.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable (stage III) or metastatic (stage IV) adenocarcinoma of the pancreas.
  • No prior treatment is permitted for stage III disease. Patients with metastatic cancer may have received previous treatment with gemcitabine or 5-FU for non-metastatic cancer, with at least 6 months passing between the completion of therapy and entry into the study.
  • This study is for patients age 18 and older.

For more information about this study or to inquire about eligibility, please contact Dr. Kenneth Yu at 646-888-4188.

Protocol

16-1066

Phase

II

Investigator

Co-Investigators