A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil Leucovorin and Liposomal Irinotecan in Older Patients with Treatment Na ve Metastatic Pancreatic Cancer (GIANT) ( s21-00700)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Metastatic Pancreatic Cancer
  • Age: Between 70 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Patient must have newly diagnosed untreated biopsy proven metastatic adenocarcinoma of the pancreas. However, previous surgery, adjuvant chemotherapy and/or radiation therapy will be allowed, provided radiation therapy is completed at least 2 weeks prior to registration and adjuvant therapy was administered more than 6 months prior to registration. Patients with the following histology are excluded: Acinar cell; Adenosquamous carcinoma. 2) Patient must have an ECOG Performance status 0-2. 3) Patient must be an English speaker with the ability to understand and complete the informed consent and questionnaires. 4) Patient must have adequate organ and marrow function as defined below, with results obtained within 4 weeks prior to registration.

You may not be eligible for this study if the following are true:

  • 1) Do not agree for the following: not take any medications or substances that are strong inhibitors or inducers of CYP3A4. 2) Patients classified without any abnormalities (“fit”) or with severe cognitive/functional impairment or high co-morbidity score (“frail”) on the screening geriatric assessment. 3) Non-English Speaker.

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