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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine/Nab-Paclitaxel plus TheraBionic Device | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nab paclitaxel | Drug | 125 mg/m2 weekly, on days 1,8, and 15 or on days 1 and 15 as a 30-40 minute infusion administered first |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 Month Progression-Free Survival Rate (PFS 6) | Progression-free survival (PFS) is defined from the time of study treatment initiation until progression or death of any cause, whichever occurs first. The six months PFS rate (PFS 6) is defined as the proportion of patients alive and progression-free at six months from treatment initiation. PFS will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Incidence | Evaluate the safety and tolerability of the combination of nab-paclitaxel, gemcitabine and AM RF EMF categorized and graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5). The adverse event incidence rate will be defined as a proportion of patients who experience adverse events among the safety population. | Up to 1 year |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anthony F Shields, MD PhD | Contact | 3135768734 | shieldsa@karmanos.org |
| Name | Affiliation | Role |
|---|---|---|
| Anthony F Shields, M.D. PhD | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karmanos Cancer Institute at McLaren Clarkston | Recruiting | Clarkston | Michigan | 48346 | United States |
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|
| Gemcitabine | Drug | 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 |
|
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| TheraBionic P1 | Device | 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. |
|
| Median Progression Free Survival (PFS) | PFS is defined from the time of study treatment initiation until progression or death of any cause, whichever occurs first. PFS will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines. The median PFS will be estimated using Kaplan-Meier estimate. | Up to 1 year |
| 6-month Overall Status rate (OS 6) | Overall survival (OS) is defined from the time of study treatment initiation until the death of any cause. The six months OS rate (OS 6) is defined as the proportion of patients alive at six months from treatment initiation. | 6 Months |
| Median OS | OS is defined from the time of study treatment initiation until death of any cause. The median OS will be estimated using Kaplan-Meier estimate. | Up to 1 year |
| Objective Response Rate (ORR) | ORR is defined as the proportion of patients with partial or complete responses based on Radiographic Determination of Treatment Response by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) by CT Scan or MRI:
| Up to 1 year |
| Disease Control Rate (DCR) | Disease control rate is defined as the proportion of patients with disease control (complete or partial response or stable disease) based on RECISTv1.1 criteria:
| Up to 1 year |
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48021 | United States |
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| Karmanos Cancer Institute at McLaren Flint | Recruiting | Flint | Michigan | 48532 | United States |
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| Karmanos Cancer Institute at McLaren Greater Lansing | Recruiting | Lansing | Michigan | 48910 | United States |
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| Karmanos Cancer Institute at McLaren Lapeer Region | Recruiting | Lapeer | Michigan | 48446 | United States |
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| Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey | Recruiting | Petoskey | Michigan | 49770 | United States |
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| Karmanos Cancer Institute at McLaren Port Huron | Recruiting | Port Huron | Michigan | 48060 | United States |
|
| ID | Term |
|---|---|
| D013660 | Taxes |
| D000068196 | Albumin-Bound Paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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