Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread

Summary

This 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.

Timeline

Start

2020-08-26

Primary completion

2026-03-02

Completion

2026-12-31

Publications

• Dotan E, Catalano P, Lenchik L, Boutin R, Yao X, Marques HS, Ioffe D, Zhen DB, Li D, Wagner LI, Simon MA, Wong TZ, O'Dwyer PJ. The GIANT trial (ECOG-ACRIN EA2186) methods paper: 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 - defining a new treatment option for older vulnerable patients. J Geriatr Oncol. 2023 Apr;14(3):101474. doi: 10.1016/j.jgo.2023.101474. Epub 2023 Mar 22.

Drugs

Indications