The primary objective of this study is to determine the efficacy of nab-paclitaxel plus cisplatin plus gemcitabine for patients with metastatic pancreatic ductal adenocarcinoma (PDA).
This is a phase 1b/2 open-label pilot study evaluating the preliminary 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 Multiple cycles may be administered until the patient is withdrawn from therapy.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 OS (overall survival) 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 (v4.0, May 2009).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle
1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
Scottsdale Health Care
Scottsdale, Arizona, United States
Rutgers - Cancer Institute of New Jersey (CINJ)
New Brunswick, New Jersey, United States
Vita Medical Associates, PC
Bethlehem, Pennsylvania, United States
Complete Response Rate
The primary objectives of this study is to pursue treatment of 25 individual patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDA) to evaluate: Complete response rate as defined by computed tomography (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). We expect to accomplish this in \> or = to 5% of patients. When a complete response (CR) is documented, a confirmatory PET scan will be obtained. If 1 or more of 10 patients demonstrate a complete response (CR), study will continue to enroll to a total of 25 patients. If intolerable adverse events or no clinical benefit are noted in the first 6 patients, study will discontinue enrollment.
Time frame: 1 yr.
Treatment-Related Toxicities
Frequency of treatment-related toxicities
Time frame: Over the course of the subjects' treatment on study, approx 1 year
Percentage Change in CA 19-9
Percentage change in CA 19-9 from baseline values
Time frame: Over the course of the subjects' treatment on study, approx 1 year
Overall Survival
Overall survival is defined as the time from study enrollment until death from any cause.
Time frame: Over the course of the subjects' treatment and participation in study, approx 18 mos
Progression-Free Survival
Progression-free survival is defined as the time from study enrollment until the first documented tumor progression (using RECIST 1.1 criteria) or death from any cause.
Time frame: Over the course of the subjects' treatment and participation in study, approx 18 mos
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