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.
Histologically or cytologically confirmed pancreatic adenocarcinoma or adeno-squamous carcinoma with liver metastasis.
Subjects with additional sites of metastasis, except known brain metastasis, are eligible.
Histologies excluded include squamous, small cell carcinoma, and acinar cell carcinoma. However, adeno-squamous histology can be enrolled.
Patients who have recurrence or metastasis after surgery and adjuvant therapy do not need repeat biopsy for confirmation of recurrence if clinical suspicion is high per scans (MRI/CT scan), with and without CA 19-9 elevation, specifically if biopsy is unsafe or technically difficult.
Patients with known brain metastasis.
Cardiac conduction abnormalities such as 2nd and 3rd heart-block requiring a pacemaker.
Patient with cardiac or abdominal pacemakers or stimulators.
Significant risk of cardiac drug toxicity due to congestive heart failure or history of myocardial infarction.
Sequential
Modified GCN+TTF treatment
Combination productThe 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.
Safety of (m)-GCN+TTF
Assessed by incidence of adverse events, as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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.
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).
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 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.
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Mayo Clinic
Lead sponsor
NovoCure Ltd.
Collaborator
