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Trial Summary


Protocol No.CTO-EA2186
StatusOPEN TO ACCRUAL
Principal InvestigatorTurk, Anita
ScopeNational
PhasePhase II
Age GroupAdult
TitleA 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)
DescriptionThis phase II trial compares two treatment combinations: gemcitabine hydrochloride and nab-paclitaxel, or fluorouracil, leucovorin calcium, and liposomal irinotecan in older patients with pancreatic cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine hydrochloride, nab-paclitaxel, fluorouracil, leucovorin calcium, and liposomal irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study may help doctors find out which treatment combination is better at prolonging life in older patients with metastatic pancreatic cancer.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Newly diagnosed untreated 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
  • Patients must have measurable disease and scans must be done within 4 weeks of registration
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesPancreas
Participating InstitutionsIU Health North Hospital
    Indiana University (IU)
      Treatment TypeTreatment
      ContactPhone: (317) 278-5632
      Email: iutrials@iu.edu