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): * Evaluate the safety and tolerability of the combination of nab-paclitaxel, gemcitabine, and amplitude-modulated radiofrequency electromagnetic fields in patients with metastatic adenocarcinoma of the pancreas. * Evaluate progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines in patients with metastatic adenocarcinoma of the pancreas treated with the combination of nab-paclitaxel, gemcitabine, and amplitude-modulated radiofrequency electromagnetic fields. * Evaluate the objective response rate (ORR) in patients with metastatic adenocarcinoma of the pancreas treated with the combination of nab-paclitaxel, gemcitabine, and amplitude-modulated radiofrequency electromagnetic fields. * Evaluate the disease control rate (DCR) in patients with metastatic adenocarcinoma of the pancreas treated with the combination of nab-paclitaxel, gemcitabine, and amplitude-modulated radiofrequency electromagnetic fields.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
125 mg/m2 weekly, on days 1,8, and 15 or on days 1 and 15 as a 30-40 minute infusion administered first
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
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.
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
RECRUITINGOverall 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
Time frame: At 6 months
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)
Time frame: Up to 1 year after treatment intervention
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
Time frame: 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: 1. Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 2.0 cm by chest x-ray, by ≥ 1.0 cm with CT or MRI scans, or ≥ 1.0 cm with calipers by clinical exam. 2. Malignant lymph nodes are to be considered pathologically enlarged and measurable if it measures ≥ 1.5 cm in short axis (greatest diameter perpendicular to the long axis of the lymph node) when assessed by scan (CT scan slice recommended being no greater than 0.5 cm). Tumor response will be summarized by count/percent with one-sided Clopper Pearson exact 95% confidence interval.
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Time frame: 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: 1. Complete Response (CR): Complete disappearance of all target and non-target lesions. No new lesions. No disease related symptoms. Any lymph nodes must have reduction in short axis to \< 1.0 cm. 2. Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline. 3. Stable Disease (SD): Does not qualify for CR, PR, Progression or Symptomatic Deterioration. Disease control rate will be summarized by count/percent with one-sided Clopper Pearson exact 95% confidence interval.
Time frame: Up to 1 year