This is a phase II open-label study evaluating the efficacy and safety of nab-paclitaxel cisplatin, and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma.
This is a phase II open-label study evaluating the efficacy and safety of nab-paclitaxel cisplatin, and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma. An individual cycle of therapy will be defined as Days 1 and 8 every 21 days. Multiple cycles may be administered until the patient is withdrawn from therapy. Overall response rates as well as individual categories of response complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) will be determined using RECIST 1.1. Time-to-event endpoints, including progression-free survival (PFS) and overall survival (OS) will be assessed using the Kaplan-Meier method. Evaluation of stable disease at 9 weeks will also be assessed. Toxicity (adverse events) will be recorded using the NCI CTCAE, version 5.0.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Cisplatin 25mg/m2 in 500 mL of NS over 60 minute IV infusion on days 1 and 8 repeated every 21 days. Gemcitabine 1000mg/m2 in 500 mL\* over 30 minute IV infusion on days 1 and 8 repeated every 21 days. Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered on days 1 and 8 repeated every 21 days.
HonorHealth Research Institute
Scottsdale, Arizona, United States
University of Miami
Miami, Florida, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, United States
12- Month Overall Survival (OS)
Evaluate the 12-month OS rate in patients with metastatic Pancreatic ductal adenocarcinoma (PDA) treated with nab-paclitaxel plus cisplatin plus gemcitabine
Time frame: 12 months
Toxicity Adverse Events (Grade ≥ 3)
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per event term), n (%)
Time frame: 12-months
Complete Response Rate (CR)
Complete response rate as defined by CT scan using RECIST 1.1 criteria and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits (from at least \> 2X ULN).
Time frame: 63 days
Disease Control Rate (CR, PR, SD) at 9 Weeks
To determine the preliminary efficacy (Disease control rate of CR+ PR+SD X 9 weeks) of the combination of nanoparticle albumin- bound paclitaxel + cisplatin + gemcitabine (NABPLAGEM) in patients with stage IV metastatic pancreatic cancer.complete response rate( RECIST 1.1), disease control rate at 9 weeks, Change and rates of normalization in CA 19-9 (or Ca125 or CEA if not expressers of CA 19-9)
Time frame: 63 days
Change in CA 19-9 or CA 125
Change in carbohydrate antigen 19-9 (CA 19-9) or cancer antigen 125 (CA 125). Both CA 19-9 and CA 125 are markers of tumor burden and treatment response.
Time frame: End of Study (36 months)
Rate of Tumor Marker Normalization
Complete response rate as defined by CT scan using RECIST 1.1 criteria and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits (from at least \> 2X ULN).
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Time frame: 12 months
Quality of Life: MD Anderson Symptom Inventory (MDASI-GI)
The MD Anderson Symptom Inventory for gastrointestinal cancer (MDASI-GI) is a site-specific MDASI module. Along with the core MDASI's 13 symptom items and 6 interference items, the MDASI-GI also assesses 5 symptoms specific to gastrointestinal cancer. Average Symptom severity Scores were measured to assess change in symptoms over time (Core Symptom Scoring: 0 - Not Present to 10 - As Bad as you can imagine; Overall symptom distress (Interference) Scoring: 0-Did not interfere to 10-Interfeard completely; Gastrointestinal Module: 0 (symptom has not been present) to 10 (the symptom was as bad as you can imagine it could be)).
Time frame: Baseline to Midpoint (C4/D1)
Pain Control: Brief Pain Inventory (BPI)
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. The BPI has been translated into dozens of languages, and it is widely used in both research and clinical settings. Average scores were measured (Scoring scale: Pain Severity: 0 - No Pain to 10 - Pain as bad as you can imagine; Pain Interference 0-Does not interfere to 10 - Completely Interferes)
Time frame: Baseline to Midpoint (C4/D1)