Actively Recruiting
Gemcitabine, Nab-paclitaxel Plus the TheraBionic P1 (an Amplitude-Modulated Radiofrequency Electromagnetic Fields) Device to Treat Metastatic Pancreatic Cancer
Led by Barbara Ann Karmanos Cancer Institute · Updated on 2025-11-05
30
Participants Needed
7
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gemcitabine, Nab-paclitaxel Plus the TheraBionic P1 (an Amplitude-Modulated Radiofrequency Electromagnetic Fields) Device to Treat Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas or mixed tumor with predominant adenocarcinoma
- At least one measurable metastatic tumor by RECIST v1.1 on CT, MRI, or PET scans
- Female patients of childbearing potential must have a negative pregnancy test within 48 hours before chemotherapy
- Sexually active females of childbearing potential and males with female partners must agree to use two forms of contraception during treatment and for 6 months after
- Age above 18 years
- Patients 80 years or older require thorough evaluation and clinical judgment for enrollment
- ECOG performance status of 0 or 1
- Adequate blood counts and organ function: ANC ≥ 1,500/mcL, platelets > 100,000/mcL, total bilirubin ≤ 1.5 times upper limit normal, AST/ALT < 2.5 times upper limit normal, creatinine ≤ 1.5 times upper limit normal or creatinine clearance > 50
- Ability to understand and sign informed consent
You will not qualify if you...
- Chemotherapy with gemcitabine and/or nab-paclitaxel within 6 months prior to study entry
- Receiving other investigational agents
- Known brain metastases
- History of allergic reactions to gemcitabine or nab-paclitaxel
- History of malignancy in past 3 years except certain treated cancers
- Use of calcium channel blockers or related agents unless modified before enrollment
- Active and uncontrolled infections requiring systemic therapy
- Uncontrolled illnesses such as heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
- Diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis, or pneumonitis
- Pregnant or breastfeeding women
- Localized resectable or locally advanced tumor
- Major surgery within 4 weeks prior to treatment
- Inability to comply with study procedures or anticipated treatment breaks of 14+ days
- Participation in another clinical interventional trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Karmanos Cancer Institute at McLaren Clarkston
Clarkston, Michigan, United States, 48346
Actively Recruiting
2
Karmanos Cancer Institute
Detroit, Michigan, United States, 48021
Actively Recruiting
3
Karmanos Cancer Institute at McLaren Flint
Flint, Michigan, United States, 48532
Actively Recruiting
4
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, United States, 48910
Actively Recruiting
5
Karmanos Cancer Institute at McLaren Lapeer Region
Lapeer, Michigan, United States, 48446
Actively Recruiting
6
Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey
Petoskey, Michigan, United States, 49770
Actively Recruiting
7
Karmanos Cancer Institute at McLaren Port Huron
Port Huron, Michigan, United States, 48060
Actively Recruiting
Research Team
A
Anthony F Shields, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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