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Modified FOLFIRINOX Alternated with Biweekly Gemcitabine plus Nab-Paclitaxel in Untreated Metastatic Adenocarcinoma of the Pancreas.

Primary Objective:
To determine whether mFFX and mGnabP administered as a combined, alternating, front-line therapy can provide longer first line treatment for patients with metastatic pancreatic cancer, with the primary metric of time to treatment failure (TTF), including progression of disease (PD), death or treatment discontinuation due to toxicity.

Secondary Objectives:
1. To determine objective response rate (ORR) of the regimen.
2. To determine progression-free survival (PFS) rate of the regimen.
3. To determine overall survival (OS) rate of the regimen.
4. To assess biomarker response (CA-19.9) to the regimen.
5. To examine safety and tolerability of the new regimen.
6. To examine health-related quality of life in patients receiving this regimen.

Exploratory Objectives:
1. To determine the tumor molecular profile prior to initiation of chemotherapy and correlate with treatment response.
2. To analyze ct-DNA as a biomarker of response to therapy and early detection of disease progression.

Protocol Number: 072011
Phase: Phase II
Applicable Disease Sites: Pancreas
Drugs Involved: 5-FU/LV
GEMCITABINE
IRINOTECAN
Nab-paclitaxel
OXALIPLATIN
Principal Investigator: Lyudmyla Berim
Scope: Local
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions:
  • RWJBarnabas Health
    • Cooperman Barnabas, Livingston
    • Jersey City Medical Center, Jersey City
    • Monmouth Medical Center
    • Newark Beth Israel Medical Center
    • Robert Wood Johnson University Hospital, Hamilton
    • Robert Wood Johnson University Hospital, Somerset
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

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