Study on Gemcitabine, Nab-paclitaxel, and TheraBionic P1 Device for Treating Metastatic Pancreatic Cancer
Sponsor: Barbara Ann Karmanos Cancer Institute
ClinicalTrials ID:NCT06576115
This clinical trial is testing a new treatment combination of chemotherapy drugs gemcitabine and nab-paclitaxel, along with a device called TheraBionic P1, to see if it is safe and effective for patients with advanced pancreatic cancer.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to find out if using a combination of two chemotherapy drugs, gemcitabine and nab-paclitaxel, together with a special device called the TheraBionic P1, can safely and effectively treat patients with advanced pancreatic cancer. The TheraBionic P1 device uses radiofrequency electromagnetic fields to target cancer cells.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced pancreatic cancer.
- Have at least one tumor that can be measured using scans like CT, MRI, or PET.
- Women who can become pregnant must have a negative pregnancy test before starting treatment.
- If sexually active, both men and women must agree to use two forms of birth control during treatment and for six months after.
- Be 18 years or older.
- Patients 80 years and older need a thorough health evaluation before joining the study.
- Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Meet specific blood test requirements for neutrophil count, platelets, liver function, and kidney function.
- Be able to understand and sign a consent form agreeing to participate in the study.
Exclusion Criteria
- Have received gemcitabine or nab-paclitaxel chemotherapy within the last six months.
- Are taking part in another clinical trial.
- Have cancer that has spread to the brain.
- Have allergies to similar drugs as those used in the study.
- Have had another cancer in the last three years, except for certain skin or prostate cancers.
- Are taking certain medications like calcium channel blockers unless they can be stopped before joining the study.
- Have an active infection that requires treatment.
- Have serious health conditions like heart failure or unstable angina.
- Have lung diseases like interstitial lung disease or pulmonary fibrosis.
- Are pregnant or breastfeeding.
- Have a tumor that can be surgically removed or is locally advanced.
- Have had major surgery within four weeks before starting the study.
- Cannot follow the study procedures or expect to need a break from treatment for 14 or more days.
- Are enrolled in another clinical trial.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Karmanos Cancer Institute | 48021 | Detroit | Michigan |
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