Phase II Randomized Clinical Trial of First-line Gemcitabine and Nab-paclitaxel With or Without L-glutamine in Advanced Pancreatic Cancer (GlutaPanc II)

Summary

This is a multi-institution, open-label, two-arm, prospective randomized controlled phase I trial with the purpose to investigate the clinical efficacy of combination gemcitabine, nab-paclitaxel, and L-glutamine compared to gemcitabine and nab-paclitaxel alone in treatment-naïve, unresectable or metastatic pancreatic cancer. This study hypothesizes that combining L-glutamine with gemcitabine and nab-paclitaxel represents a superior therapeutic strategy over gemcitabine and nab-paclitaxel alone in the first-line treatment of advanced PDAC based on the positive results of the phase I GlutaPanc trial that demonstrated the feasibility and preliminary efficacy of combining glutamine supplementation with gemcitabine and nab-paclitaxel in the first-line treatment of advanced PDAC. This study also plans to characterize the safety and secondary endpoints of efficacy (ORR and PFS) of the combination in this cohort. Additionally, the study will characterize the anti-cachexia effects of the study combination compared to control through standard measures such as weight gain, weight stability, and body composition assessments. Lastly, this study will conduct correlative studies on study treatment impact on tumor metabolism, the gut microbiome composition and bacterial metabolism, the plasma and fecal metabolome, and inflammatory signaling, relative to control, to identify potential biomarkers to guide selection of candidates ideal for L-glutamine-based combination therapy.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Gemcitabine (1000 mg/m2)

  1000 mg/m\^2 IV on D1, 8, and 15 of cycle

• Drug
  Nab-paclitaxel

  125 mg/m\^2 IV on D1, 8, and 15 of cycle

• Drug
  L-glutamine

  0.3 g/kg oral BID

Location