A Study Comparing Two Standard Chemotherapy Treatments for Newly Diagnosed Metastatic Pancreatic Cancer

Share
Print

Full Title

PASS-01- Pancreatic Adenocarcinoma Signature Stratification for Treatment - 01

Purpose

People with metastatic pancreatic ductal adenocarcinoma are usually treated with one of two standard chemotherapy treatments (regimens):

  • Modified FOLFIRINOX (mFFX), which includes folinic acid (leucovorin), 5-fluorouracil, irinotecan, and oxaliplatin
  • Gemcitabine combined with Abraxane (GA). Abraxane is also called nab-paclitaxel.

Even though mFFX and GA are standard treatments, researchers do not know which one is more effective. The purpose of this study to compare the benefits of these two standard chemotherapy regimens when given as the first treatment in people with metastatic pancreatic cancer.

Patients will be randomly assigned to receive either mFFX or GA; both regimens are given intravenously (by vein). Researchers will also study a number of innovative approaches to help guide treatment for participants, including tumor models made from patients’ cells, circulating tumor cells, and other gene profiling studies.

Eligibility

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

  • Patients must have previously untreated metastatic pancreatic ductal adenocarcinoma and be eligible to receive mFFX or GA chemotherapy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

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

Protocol

21-067

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators