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

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

NCT ID: NCT06576115

Condition: Metastatic Pancreatic Adenocarcinoma

Conditions: Official terms:
Paclitaxel
Gemcitabine

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Nab paclitaxel
Description: 125 mg/m2 weekly, on days 1,8, and 15 or on days 1 and 15 as a 30-40 minute infusion administered first
Arm group label: Gemcitabine/Nab-Paclitaxel plus TheraBionic Device

Other name: Abraxane

Intervention type: Drug
Intervention name: Gemcitabine
Description: 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
Arm group label: Gemcitabine/Nab-Paclitaxel plus TheraBionic Device

Other name: Gemzar

Intervention type: Device
Intervention name: TheraBionic P1
Description: 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.
Arm group label: Gemcitabine/Nab-Paclitaxel plus TheraBionic Device

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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). Exclusion Criteria: - 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Karmanos Cancer Institute

Address:
City: Detroit
Zip: 48021
Country: United States

Contact:
Last name: Anthony F Shields, M.D. PhD
Email: shieldsa@karmanos.org

Investigator:
Last name: Anthony F Shields, M.D. PhD
Email: Principal Investigator

Investigator:
Last name: Mohammed N Al Hallak, M.D.
Email: Sub-Investigator

Investigator:
Last name: Wasif Saif, M.D.
Email: Sub-Investigator

Start date: October 2024

Completion date: July 2027

Lead sponsor:
Agency: Barbara Ann Karmanos Cancer Institute
Agency class: Other

Source: Barbara Ann Karmanos Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06576115