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Anti-metabolites

Gemcitabine + Nab-paclitaxel + TheraBionic P1 for Pancreatic Cancer

Phase 2

Waitlist Available

Led By Anthony F Shields, M.D. PhD

Research Sponsored by Barbara Ann Karmanos Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age above 18 years

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Must not have

Patient with known diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis or pneumonitis.

Patients has undergone major surgery, other than diagnostic surgery or procedures, within 4 weeks prior to the treatment day.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Summary

"This trial aims to find out if using a combination of nab-paclitaxel, gemcitabine, and a device called Therabionic P1 is safe and helpful for patients with pancreatic

Who is the study for?

This trial is for patients with metastatic pancreatic cancer. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria and have a diagnosis of adenocarcinoma of the pancreas.

What is being tested?

The study tests if combining chemotherapy drugs (Gemcitabine and Nab-paclitaxel) with a device called TheraBionic P1, which uses radiofrequency electromagnetic fields, can safely and effectively treat metastatic pancreatic cancer.

What are the potential side effects?

Potential side effects may include those commonly associated with chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts; specific side effects related to the TheraBionic P1 device are not detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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I am fully active or can carry out light work.

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I can understand and am willing to sign the consent form.

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I have at least one tumor that can be measured on scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a lung condition such as interstitial lung disease or pulmonary fibrosis.

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I had major surgery less than 4 weeks ago.

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My tumor can be surgically removed or is in an advanced local stage.

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I am allergic to drugs similar to gemcitabine or nab-paclitaxel.

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I've had chemotherapy with gemcitabine or nab-paclitaxel in the last 6 months.

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I am not taking calcium channel blockers, or I can stop them before joining the study.

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I do not have brain metastases.

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I do not have any active infections needing treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

6 Month Progression-Free Survival Rate (PFS 6)

Secondary study objectives

6-month Overall Status rate (OS 6)

Adverse Event Incidence

Disease Control Rate (DCR)

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Gemcitabine/Nab-Paclitaxel plus TheraBionic DeviceExperimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nab paclitaxel

2014

Completed Phase 2

~580

Gemcitabine

2017

Completed Phase 3

~1920

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Barbara Ann Karmanos Cancer InstituteLead Sponsor

164 Previous Clinical Trials

9,218 Total Patients Enrolled

Anthony F Shields, M.D. PhDPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute

~20 spots leftby Jul 2027

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