Monthly Alternating NALIRIFOX and GnP in the First-Line Setting for Metastatic Pancreatic Ductal Adenocarcinoma
Northwell Health
Summary
A prospective, interventional, single-center, single-arm, open-label, phase II study for patients with metastatic pancreatic cancer. The intervention consists of monthly alternating standard chemotherapy regimens-NALIRIFOX and GnP. The hypothesis is that induction therapy with alternating NALIRIFOX and GnP has better efficacy compared to historical observation.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion: * \>18 years of age * Histologically proven pancreatic ductal adenocarcinoma, poorly differentiated carcinoma, or adenosquamous carcinoma * Radiographic evidence of metastatic disease * At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Metastatic relapse of previously resected pancreatic cancer is allowed provided the patient is more than 6 months from last SOC adjuvant treatment * ECOG PS 0-1 * Laboratory assessments within 14 days as indicated below: * Hemoglobin \> 9.0 g/dL (patients with hemoglobin \< 9 g/dL may be transfused…
Interventions
- DrugNALIRIFOX
NALIRIFOX consists of 5-FU 2400 mg/m2 over 46 hours, liposomal irinotecan 50 mg/m2, and oxaliplatin 60 mg/m2, which would be given on Day 1 and Day 15
- DrugGemcitabine plus nab-Paclitaxel (GnP)
GnP consists of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2, given on Days 1, 8, and 15.
Locations (7)
- Imbert Cancer CenterBay Shore, New York
- Northern Westchester Cancer CenterMount Kisco, New York
- Long Island Jewish Medical CenterNew Hyde Park, New York
- Zuckerberg Cancer CenterNew Hyde Park, New York
- Manhattan Eye, Ear and Throat HospitalNew York, New York
- NHPP Medical Oncology at Rego ParkRego Park, New York