The main objective of the clinical trial is to determine if modified FOLFIRINOX (mFFX) alternated with biweekly Gemcitabine plus Nab-Paclitaxel (mGnabP) administered as a combined, front-line therapy will result in longer time to treatment failure (TTF) compared to the current standard of care with mFFX alone in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
1. 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. • Primary endpoint: TTF (treatment discontinuation due to toxicity, disease progression, or death). 2. 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. • Secondary endpoints: 1. ORR as determined by the proportion of subjects with either complete response (CR) or partial response (PR), as defined by RECIST 1.1. 2. PFS as determined by the time interval from the date of first dose of study regimen to first documented PD or death from any cause, whichever occurs first. 3. Overall survival (OS) as defined as the time interval from the date of the first dose of study regimen to date of death from any cause. 4. Biomarker response, measured by serum CA 19-9 levels every 4 weeks. 5. Safety and tolerability of the mFFX alternating with mGnabP regimen; Grade 3 and 4 toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Follow up for toxicity will be recorded for the first 30 days following the last chemotherapy cycle, and any long-term toxicity will be followed for up to 2 years after completion of study therapy. 3\. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
modified Folfirinox every 2 weeks and biweekly Gemcitabine plus Nab-Paclitaxel
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, United States
RWJBarnabas Health - Jersey City Medical Center, Jersey City
Jersey City, New Jersey, United States
RWJBarnabas Health - Saint Barnabas Medical Center, Livingston
Livingston, New Jersey, United States
Time to treatment failure (TTF)
The primary objective of this study is to determine time to treatment failure (TTF) in patients with metastatic pancreatic cancer treated in front line setting with mFOLFIRINOX (mFFX) alternating with biweekly Gemcitabine and nab-Paclitaxel (mGnabP).
Time frame: 24 weeks
Response Evaluation Criteria in Solid Tumors (RECIST 1.1
Response will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1 by independent radiology review) at 8 week intervals.
Time frame: 24 weeks
Progression-free survival (PFS)
To determine progression-free survival (PFS) rate of the regimen.
Time frame: 24 weeks
Overall survival (OS)
To determine overall survival (OS) rate of the regimen.
Time frame: 24 weeks
Safety and tolerability assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
4\. Safety and tolerability of the mFFX alternating with mGnabP regimen; Grade 3 and 4 toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Follow up for toxicity will be recorded for the first 30 days following the last chemotherapy cycle, and any long-term toxicity will be followed for up to 2 years after completion of study therapy.
Time frame: 24 weeks
EORTC QLQ-CIPN20 questionnaire
Patient reported outcomes, examined through the EORTC QLQ-CIPN20 questionnaire
Time frame: Administered at baseline prior to start of therapy, then every 8 weeks while receiving therapy, and at the end of treatment, average of 1 year
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Monmouth Medical Center
Long Branch, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset
Somerset, New Jersey, United States
Correlation between variation in variant allele fraction (% cfDNA) or amplifications and tumor objective response during chemotherapy
Correlation between variation in the variant allele fraction (% cfDNA) or amplifications and tumor objective response during chemotherapy
Time frame: Assessed at baseline prior to therapy, every 8 weeks interval through duration of therapy, and at end of treatment, average 1 year