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8110 Gatehouse Road, Falls Church, VA 22042

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 (EA2186-GIANT)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT04233866

Background Information

This study is being done to determine which of two treatment combinations: Gemcitabine and Nab-paclitaxel or 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan, is more effective at lengthening survival time for less fit patients over the age of 70 years with metastatic pancreatic cancer (mPCA). Currently, there is no known best practice for this type of patient.

There currently is no standard treatment for this type of cancer, but the commonly used treatment approach is chemotherapy using various agents including those used in this trial.

This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

  • Adults over the age of 70
  • Participant 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
  • Patient must agree not to take any medications or substances that are strong inhibitors or inducers of CYP3A4. Those who are randomized to liposomal irinotecan treatment arm should avoid drugs that are UGT1A1 inhibitors
  • Additional eligibility in protocol

Ineligibility Information

  • Patients with the following histology are excluded: Acinar cell; Adenosquamous carcinoma
  • Additional ineligibility in protocol

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT04233866