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

Official title

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

Overview

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.

Interventions

• Drug Nab 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
• Drug Gemcitabine
  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
• Device TheraBionic 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.

Primary outcome measures

• 6 Month Progression-Free Survival Rate (PFS 6) [Time frame: 6 months]

Secondary outcome measures (6)

• 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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 7 centers

• Karmanos Cancer Institute at McLaren Clarkston — Clarkston
• Karmanos Cancer Institute — Detroit
• Karmanos Cancer Institute at McLaren Flint — Flint
• Karmanos Cancer Institute at McLaren Greater Lansing — Lansing
• Karmanos Cancer Institute at McLaren Lapeer Region — Lapeer
• Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey — Petoskey
• Karmanos Cancer Institute at McLaren Port Huron — Port Huron

Identifiers

NCT: NCT06576115 · 2023-104

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗