Treatment of Patients With Metastatic Pancreatic Cancer With Gemcitabine and Nab-Paclitaxel and Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF)
Summary
The goal of this study is to learn if the combination of nab-paclitaxel, gemcitabine and an Amplitude-Modulated Radiofrequency Electromagnetic Fields device (Therabionic P1) is safe and effective for patients with adenocarcinoma of the pancreas.
Arms & interventions
- DrugNab paclitaxel
125 mg/m2 weekly, on days 1,8, and 15 or on days 1 and 15 as a 30-40 minute infusion administered first
- DrugGemcitabine
1000 mg/m2 weekly, on day 1,8 and 15 or 1000 mg/m2 weekly, on day 1 and 15 over 30 minutes after nab- paclitaxel infusion
- DeviceTheraBionic P1
This treatment consists of delivering preset low levels of radio waves into the body with a spoon-shaped antenna placed in the mouth, three times a day, for an hour each time.
Outcome measures
Primary
6 Month Progression-Free Survival Rate (PFS 6)
Progression-free survival (PFS) is defined from the time of study treatment initiation until progression or death of any cause, whichever occurs first. The six months PFS rate (PFS 6) is defined as the proportion of patients alive and progression-free at six months from treatment initiation. PFS will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines.
Time frame: 6 months
Secondary
Adverse Event Incidence
Time frame: Up to 1 year
Median Progression Free Survival (PFS)
Time frame: Up to 1 year
6-month Overall Status rate (OS 6)
Time frame: 6 Months
Median OS
Time frame: Up to 1 year
Objective Response Rate (ORR)
Time frame: Up to 1 year
Disease Control Rate (DCR)
Time frame: Up to 1 year
Eligibility criteria
Study locations (7)
Karmanos Cancer Institute at McLaren Clarkston
Clarkston, Michigan, 48346
Karmanos Cancer Institute
Detroit, Michigan, 48021
Karmanos Cancer Institute at McLaren Flint
Flint, Michigan, 48532
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, 48910
Karmanos Cancer Institute at McLaren Lapeer Region
Lapeer, Michigan, 48446
Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey
Petoskey, Michigan, 49770
Karmanos Cancer Institute at McLaren Port Huron
Port Huron, Michigan, 48060