A Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Untreated Metastatic Pancreatic Cancer

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Full Title

A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naïve Metastatic Pancreatic Cancer (GIANT) (EA2186) (CIRB)

Purpose

It is not known what the best treatment is for vulnerable patients over age 70 who are diagnosed with metastatic pancreatic cancer. In this study, researchers are comparing two combinations of chemotherapy drugs to see which is more effective for lengthening the lives of older patients newly diagnosed with this disease.

Patients will be randomly assigned to receive either gemcitabine/nab-paclitaxel or 5-fluorouracil/leucovorin/liposomal irinotecan. These medications are given intravenously (by vein).

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 adenocarcinoma.
  • Prior surgery, chemotherapy, and/or radiation therapy are allowed if radiation therapy was completed at least 2 weeks before entering the study and chemotherapy was completed at least 6 months before.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 70 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Armin Shahrokni at 646-888-3651.

Protocol

20-417

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators