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

October 8, 2020

Protocol: ECOG – EA2186

SCHEMA ECOG EA2186

Please Note: Below is a partial list  of eligibility, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 or (810) 762-8038. Thank you!

Eligibility:

  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. Patients must be at least or equal to 70 years of age.
  3. ECOG Performance Status 0-2.
  4. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this protocol. HIV (+) patients who are on ritonavir or/and cobicistat-based regimen must be switched to alternative ART.
  5. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this protocol, patients should be class 2B or better.
  6. Patient must have measurable disease.

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