Gemcitabine, Nab-paclitaxel Plus the TheraBionic P1 (an Amplitude-Modulated Radiofrequency Electromagnetic Fields) Device to Treat Metastatic Pancreatic Cancer

NCT06576115 | Recruiting Phase 2 FDA Device

• 1 other identifier: 2023-104
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Metastatic Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (6)

• Adverse Event Incidence

  Up to 1 year

• Median Progression Free Survival (PFS)

  Up to 1 year

• 6-month Overall Status rate (OS 6)

  6 Months

• Median OS

  Up to 1 year

• Objective Response Rate (ORR)

  Up to 1 year

Study Arms (1)

Gemcitabine/Nab-Paclitaxel plus TheraBionic Device

EXPERIMENTAL

Metastatic pancreatic cancer patients will be treated with amplitude-modulated radiofrequency electromagnetic fields using TheraBionic device in combination with standard chemotherapy, gemcitabine- nab-paclitaxel. amplitude-modulated radiofrequency electromagnetic fields will be delivered by the TheraBionic device.

Drug: Nab paclitaxel; Drug: Gemcitabine; Device: TheraBionic P1

Interventions

Nab paclitaxel DRUG

125 mg/m2 weekly, on days 1,8, and 15 or on days 1 and 15 as a 30-40 minute infusion administered first

Also known as: Abraxane

Gemcitabine/Nab-Paclitaxel plus TheraBionic Device

Gemcitabine DRUG

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

Also known as: Gemzar

Gemcitabine/Nab-Paclitaxel plus TheraBionic Device

TheraBionic P1 DEVICE

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.

Gemcitabine/Nab-Paclitaxel plus TheraBionic Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically proven advanced metastatic adenocarcinoma of the pancreas. Patients with mixed tumor with predominant adenocarcinoma pathology can be enrolled.
• One or more measurable metastatic tumors per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies CT or MRI or PET scans
• If female patient is of childbearing potential must have a negative serum pregnancy test (βhCG) documented up to 48 hrs prior to administration of chemotherapy.
• Females of childbearing potential and males with female partners of childbearing potential, if sexually active, must agree to use two forms of contraception during the period of administration of study drug and up to 6 months after the end of treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
• Age above 18 years
• Based on prior studies, patients 80 years of age and older are considered to be at higher risk for fatal neutropenic sepsis. These patients should be thoroughly evaluated including geriatric assessment prior to enrollment. Clinical judgment should be exercised regarding patients' susceptibility for sepsis or infection (presence of biliary tract infection, uncontrolled diabetes, etc.). The patients in this age group should be not enrolled should there be any concern for rapid deterioration of clinical and functional status.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Parameter Levels:
• Absolute neutrophil count (ANC) ≥ 1,500/mcL Platelets \> 100,000/mcL Total bilirubin ≤ 1.5 X institutional upper limit of normal AST(SGOT)/ALT(SGPT) \< 2.5 X ins Creatinine ≤ 1.5 X institutional upper limit of normal Or CrCL \> 50
• Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

You may not qualify if:

• Patients who have had chemotherapy with gemcitabine and/or nab-paclitaxel within six months prior to entering the study in the adjuvant or neo-adjuvant setting.
• Patients receiving any other investigational agents.
• Patients with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• History of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and nab-paclitaxel.
• No history of malignancy in last 3 years except cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer, who are considered to be eligible.
• Patients receiving calcium channel blockers and any agent blocking L-type of T-type Voltage Gated Calcium Channels such as amlodipine, nifedipine, ethosuximide are not allowed in the study unless their medical treatment is modified to exclude calcium channel blockers prior to enrollment. (Refer to Appendix D for a comprehensive list of excluded medications)
• Patients with active and uncontrolled bacterial, viral or fungal infection requiring systemic therapy. Patients can be reevaluated for the study if the infection is deemed to be under control and the systemic therapy is completed.
• Uncontrolled intercurrent illness including, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or could compromise patients' safety.
• Patient with known diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis or pneumonitis.
• Pregnant women are excluded from this study because of potential risk for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy and AM RF EMF, patients who are breastfeeding will be excluded to participate in this study.
• Patient has localized resectable or locally advanced tumor.
• Patients has undergone major surgery, other than diagnostic surgery or procedures, within 4 weeks prior to the treatment day.
• Patients is unable to comply with study procedures or anticipating a situation that would result in a treatment break for 14 or more consecutive days after the start of the study.
• Patient is enrolled in any other clinical interventional trial.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead

Study Sites (7)

Karmanos Cancer Institute at McLaren Clarkston

Clarkston, Michigan, 48346, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48021, United States

RECRUITING

Karmanos Cancer Institute at McLaren Flint

Flint, Michigan, 48532, United States

RECRUITING

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, 48910, United States

RECRUITING

Karmanos Cancer Institute at McLaren Lapeer Region

Lapeer, Michigan, 48446, United States

RECRUITING

Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey

Petoskey, Michigan, 49770, United States

RECRUITING

Karmanos Cancer Institute at McLaren Port Huron

Port Huron, Michigan, 48060, United States

RECRUITING

MeSH Terms

Interventions

Taxes; Albumin-Bound Paclitaxel; Gemcitabine

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Anthony F Shields, M.D. PhD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony F Shields, MD PhD

CONTACT

3135768734; shieldsa@karmanos.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Center Director

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: February 28, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 5, 2025

Record last verified: 2025-11

Locations

US (7)