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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 57122 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| Therabionics | OTHER |
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The objective of this research is to find out what effects (good and bad), the combination of gemcitabine and nab-paclitaxel therapy (GEM-ABR for the rest of the document), standard chemotherapy for pancreatic cancer, and the TheraBionic device has on participants' condition.
Primary Objective(s): The primary objective of this study is to evaluate the efficacy of the combination of nab-paclitaxel, gemcitabine, and amplitude-modulated radiofrequency electromagnetic fields in improving 6-month overall survival (OS) rates in patients with metastatic adenocarcinoma of the pancreas.
Secondary Objective(s):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GEM-ABR [Gemcitabine - Abraxane (nab-Paclitaxel)] with 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. |
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| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival is defined from the time of study treatment initiation until death of any cause. Six months overall survival (OS 6) is defined as the proportion of patients alive at six months from treatment initiation. All participant demographic and clinical characteristics will be summarized using mean (standard deviation) and count (percent) for continuous and categorical variables, respectively. Primary analysis will calculate the overall survival rate at 6-months with one-sided 95% confidence interval | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidences of Adverse Events | The incidence of treatment-emergent toxicities/adverse events (AEs) and severe adverse events in terms categorized and graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5) | Up to 1 year after treatment intervention |
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Inclusion Criteria:
Organ and Marrow Function Absolute neutrophil count (ANC) ≥ 1,500/mcL Platelets* ≥ 100,000/mcL Hemoglobin* ≥ 7 g/dL *It is acceptable to transfuse packed red blood cells (PRBC) and platelets at the time of enrollment to meet the eligibility criteria.
Total bilirubin ≤ 1.5 X institutional upper limit of normal AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal (≤ 5 x ULN, if liver metastasis) 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | 3367136912 | ahumbert@wakehealth.edu | |
| Ravi Paluri, MD | Contact | rpaluri@wakehealth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ravi Paluri, MD | Wake Forest Baptist Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D013660 | Taxes |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
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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 | Device | This treatment consists of delivering 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. |
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| Progression-Free Survival |
Progression-free survival is defined from the time of study treatment (amplitude-modulated radiofrequency electromagnetic fields plus chemo) initiation until progression according to RECISTv1.1 guidelines or death of any cause, whichever occurs first, as measured throughout the study. Kaplan-Meier curves will be constructed to assess progression-free survival with estimated 6-month and median times with 95% confidence intervals |
| Up to 1 year |
| Tumor Response | Objective tumor response based on CT or MRI scans. These will be evaluated according to the RECISTv1.1 criteria:
Tumor response will be summarized by count/percent with one-sided Clopper Pearson exact 95% confidence interval. | Up to 1 year |
| Disease Control Rate | Disease control rate defined as the proportion of patients with disease control (complete or partial response or stable disease) based on RECISTv1.1 criteria:
Disease control rate will be summarized by count/percent with one-sided Clopper Pearson exact 95% confidence interval. | Up to 1 year |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D003562 |
| Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |