Using gemcitabine and nab-paclitaxel, the investigators hope to establish the differential ability of local and cytologically positive disease to respond to this regimen, and in particular, the frequency of cytologic conversion from positive to negative in such patients. The investigators also can begin to assess the value of maximum local therapy, including surgery, in patients who cytologically convert from positive to negative.
This research study is a Phase Ib clinical trial. It will assess the frequency of cytological conversion in patients with pancreatic adenocarcinoma and positive peritoneal cytology as a sole metastatic site following gemcitabine nab-paclitaxel. Subjects must have a newly diagnosed stage 4 untreated metastatic pancreatic ductal cancer with positive peritoneal cytology as a sole metastatic site and meet all inclusion/exclusion criteria. Treatment consists of 4 week treatment cycles. Nab-paclitaxel and gemcitabine will be administered on days 1,8, and 15.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Administered by intravenous infusion over 30 minutes.
Administered by intravenous infusion over 30-40 minutes.
Virginia mason medical Center
Seattle, Washington, United States
RECRUITINGFrequency of cytological conversion
To assess the frequency of cytological conversion in patients with pancreatic adenocarcinoma and positive peritoneal cytology as a sole metastatic site following gemcitabine nab-paclitaxel.
Time frame: An average of 6 months
Progression-free survival (PFS)
Assess progression-free survival (PFS)
Time frame: Up to 5 years
Overall survival (OS)
Assess overall survival (OS).
Time frame: Up to 5 years
Overall response rate
Assess overall response rate.
Time frame: Up to 5 years
Response rate by CA19-9
Assess response rate as measured by serial CA19-9 determinations.
Time frame: An average of 1 year
Response rate by RECIST criteria 1.1
Assess response rate as measured by RECIST criteria 1.1 radiographic criteria.
Time frame: Assessment approximately every 8 weeks during treatment up to 5 years
Ability to achieve R0 (complete)
Assess the ability to achieve R0 (complete) resection rate in anatomically appropriate patients.
Time frame: At time of surgery, approximately 6 months after enrollment
Local disease control rate.
Measure the local disease control rate.
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Time frame: Baseline, and approximately every 8 weeks during treatment. Up to 5 years
Pattern of disease recurrence
Observe the pattern of disease recurrence (both in anatomic space and time) in the above patient population.
Time frame: Up to 5 years