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Treatment of Patients With Metastatic Pancreatic Cancer With Gemcitabine and Nab-Paclitaxel and Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF)

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Michigan
Karmanos Cancer Institute at McLaren Clarkston
RECRUITING
Clarkston
Karmanos Cancer Institute
RECRUITING
Detroit
Karmanos Cancer Institute at McLaren Flint
RECRUITING
Flint
Karmanos Cancer Institute at McLaren Greater Lansing
RECRUITING
Lansing
Karmanos Cancer Institute at McLaren Lapeer Region
RECRUITING
Lapeer
Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey
RECRUITING
Petoskey
Karmanos Cancer Institute at McLaren Port Huron
RECRUITING
Port Huron
Contact Information
Primary
Anthony F Shields, MD PhD
shieldsa@karmanos.org
3135768734
Time Frame
Start Date: 2025-02-28
Estimated Completion Date: 2027-07
Participants
Target number of participants: 30
Treatments
Experimental: Gemcitabine/Nab-Paclitaxel plus TheraBionic Device
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.
Related Therapeutic Areas
Sponsors
Leads: Barbara Ann Karmanos Cancer Institute

This content was sourced from clinicaltrials.gov

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