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.
Advanced or unresectable, histologically confirmed pancreatic ductal adenocarcinoma (PDAC, new diagnosis or recurrent, where recurrent tumor does not need to be histologically-confirmed) referred to Cedars-Sinai Medical Center (CSMC), Samuel Oschin Comprehensive Cancer Institute (SOCCI), USC, or UC Irvine for first-line chemotherapy. Prior neoadjuvant or adjuvant chemotherapy and/or chemoradiation is allowed but must have been completed ≥6 months prior to recurrence.
Age ≥18 years
ECOG performance status ≤2 or Karnofsky performance status ≥60%
Demonstrate adequate organ and marrow function
Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
Has previously received chemotherapy for metastatic disease (treatment with neoadjuvant or adjuvant therapy is allowed so long as treatment was completed ≥6 months prior to recurrence).
Has pre-existing grade ≥3 neuropathy.
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
Parallel
Gemcitabine (1000 mg/m2)
Drug1000 mg/m\^2 IV on D1, 8, and 15 of cycle
Nab-paclitaxel
Drug125 mg/m\^2 IV on D1, 8, and 15 of cycle
L-glutamine
Drug0.3 g/kg oral BID
Overall Survival (OS)
To determine the clinical efficacy of L-glutamine supplementation with gemcitabine and nab-paclitaxel to gemcitabine and nab-paclitaxel alone in the first-line treatment of advanced pancreatic cancer
Progression Free Survival (PFS)
Objective Response Rate (ORR)
Safety based on NCI CTCAE Version 5.0
Weight change
Weight gain, as measured by the change in body weight from baseline to 12 weeks of study treatment
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Jun Gong, MD
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
