This is a Phase I/Ib trial, single-center, non-randomized, open-label study of Protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN) Combined with Tumor Treatment Fields (TTF) and G+TTF maintenance therapy in patients with metastatic pancreatic cancer.
GCN is predicted to be the front-line therapy for biliary and pancreatic cancer in the future given excellent results of current early clinical trials (ORR ≥ 67% in pancreatic cancer). This will change standard of care for front-line therapy in patients with stage IV pancreatic cancer. In this cohort of patients' tolerability after 6 cycles of therapy will be a challenge. Investigators hypothesize that developing a maintenance strategy with TTF+G will be cutting edge approach and can potentially transform front-line standard of care therapy in patients with stage IV pancreatic cancer. If this pilot study proves fruitful then a larger study to confirm findings can be conducted.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The regimen will consist of gemcitabine (G) administered at a dose of 800 mg/m2, cisplatin (C) 30 mg/m2, and protein-bound paclitaxel (N) 150 mg/m2 administered on cycle 1 day 1 and every 2 weeks thereafter and TTF will be administered daily (150kHz 18 hours/day) starting with Cycle 1 Day 1 (dose level 1). One cycle consists of 28 days including 2 chemotherapy treatments (same regimen studied in the PAXG trial: Reni BJC 2016 without capecitabine). After completing 6 cycles, patients will then transition to a maintenance phase of G administered at a dose of 1000 mg/m2 every 2 weeks and daily TTF (150 KHZ 18 hours/day) until progression of disease (POD) per RECIST v1.1.
Mayo Clinic in Florida
Jacksonville, Florida, United States
RECRUITINGSafety of (m)-GCN+TTF
Assessed by incidence of adverse events, as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: 28 days
Progression-free Survival (PFS)
PFS is defined as the time from the date of registration to the earliest date of documented evidence of recurrent or progressive disease or the date of death due to any cause.
Time frame: Six months
Overall Response Rate (ORR)
ORR will be assessed by the percentage of patients achieving complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), as evaluated using the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).
Time frame: Six months
Overall Survival (OS)
OS is defined as the time from the date of registration to the date of death due to any cause, or the date of last contact (censored observations).
Time frame: Twelve months
Time to Progression (TTP)
TTP is defined as the length of time from the date of registration until the disease starts to get worse or spread to other parts of the body.
Time frame: Twelve months
Quality of Life - EORTC QLQ-C30
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 is a 30-item questionnaire a questionnaire used to assess the quality of life of cancer patients. Twenty-eight questions are answered on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, and 4= very much), and two questions are answered on a scale of 1-7 (1= very poor and 7=excellent). Higher summary scores indicate better health related quality of life.
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Time frame: Every 2 months, up to 12 months