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 Multiple cycles may be administered until the patient is withdrawn from therapy.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 (CR, PR, SD, and PD) will be determined using RECIST 1.1 (Frese 2012). Time-to-event endpoints, including PFS and OS will be assessed using the Kaplan-Meier method (Kaplan 1958). 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
Evaluate the 12-month OS rate in patients with metastatic PDA treated with nab-paclitaxel plus cisplatin plus gemcitabine
Time frame: 360 days
Change in tumor markers
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
Quality of Life: MD Anderson Symptom Inventory (MDASI-GI)
Changes in patient's self-reported quality of life will be determined by administering the MD Anderson Symptom Inventory (MDASI-GI). This questionnaire asks about severity of symptoms using numbers (0 = not present to 10 = as bad as you can imagine).
Time frame: 63 days
Pain Control: Brief Pain Inventory (BPI)
Changes in patient's self-reported pain levels will be determined by administering the Brief Pain Inventory (BPI). This form asks about severity of pain using numbers (0 = not present to 10 = as bad as you can imagine).
Time frame: 63 days
Potential tumor biomarkers
Tumor biopsy testing will be completed to evaluate potential biomarkers in the tumor to evaluate various copy number variant signatures
Time frame: 63 days
Disease Response
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: 63 days