Trial of First-line L-glutamine With Gemcitabine and Nab-paclitaxel in Advanced Pancreatic Cancer

Gemcitabine will be administered at 600, 800, or 1000 mg/m2 intravenous (IV) infusion over 30 minutes on days 1, 8, and 15 (every 28-day cycles) during the treatment period. Gemcitabine will be administered immediately after the infusion of nab-paclitaxel. Pre-medication with may be administered per institutional standard practice at the investigator's discretion with gemcitabine.

Nab-paclitaxel will be administered at 75, 100, or 125 mg/m2 intravenous (IV) infusion over 30 minutes on days 1, 8, and 15 (every 28-day cycles) during the treatment period. Nab-paclitaxel will be given first, before infusion of gemcitabine. Pre-medication for nab-paclitaxel may be administered per institutional standard practice at investigator's discretion.

The dose levels of L-glutamine in this study will be 0.1, 0.2, and 0.3 g/kg oral twice daily (rounded to nearest 5 g with an upper limit of 15 g twice daily (30 g/day) for any dose level) taken at the same time each day during the treatment period. L-glutamine will be administered for 1 week (+/-1 day) prior to addition of gemcitabine/nab-paclitaxel. Each dose of L-glutamine should be mixed immediately before ingestion with 8 oz. (240 mL) of a cold or room temperature beverage, such as water, milk or apple juice, or 4 oz. (120 mL) to 6 oz. (177 mL) of food such as applesauce or yogurt. L-glutamine is formulated in 5 gram packets as a white crystalline powder in paper-foil-plastic laminate. Complete dissolution is not required prior to administration.