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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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 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.
Karmanos Cancer Institute at McLaren Clarkston
Clarkston, Michigan, United States
RECRUITINGKarmanos Cancer Institute
Detroit, Michigan, United States
RECRUITINGKarmanos Cancer Institute at McLaren Flint
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.
Time frame: 6 months
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.
Time frame: Up to 1 year
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 year
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Flint, Michigan, United States
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, United States
RECRUITINGKarmanos Cancer Institute at McLaren Lapeer Region
Lapeer, Michigan, United States
RECRUITINGKarmanos Cancer Institute at McLaren Northern Michigan, Petoskey
Petoskey, Michigan, United States
RECRUITINGKarmanos Cancer Institute at McLaren Port Huron
Port Huron, Michigan, United States
RECRUITINGObjective 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: 1. Complete Response (CR): Complete disappearance of all target and non-target lesions (with the exception of lymph nodes mentioned below). No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to \< 1.0 cm. All disease must be assessed using the same technique as baseline. 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.
Time frame: 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: 1. Complete Response (CR): Complete disappearance of all target and non-target lesions (with the exception of lymph nodes mentioned below). No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to \< 1.0 cm. All disease must be assessed using the same technique as baseline. 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. 3. Stable disease: Does not qualify for CR, PR, Progression or Symptomatic Deterioration. All target measurable lesions must be assessed using the same techniques as baseline.
Time frame: Up to 1 year