Gemcitabine & Nab-Paclitaxel in Pancreatic Adenocarcinoma With Positive Peritoneal Cytology
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|ClinicalTrials.gov Identifier: NCT03703089|
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma||Drug: Gemcitabine Drug: nab-paclitaxel||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gemcitabine and Nab-Paclitaxel in Pancreatic Adenocarcinoma With Positive Peritoneal Cytology as a Sole Metastatic Site, a Pilot Study|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 1, 2021|
Experimental: Gemcitabine and Nab-Paclitaxel
Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle.
Administered by intravenous infusion over 30 minutes.
Other Name: GEMZAR
Administered by intravenous infusion over 30-40 minutes.
Other Name: Abraxane
- Frequency of cytological conversion [ Time Frame: An average of 6 months ]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.
- Progression-free survival (PFS) [ Time Frame: Up to 5 years ]Assess progression-free survival (PFS)
- Overall survival (OS) [ Time Frame: Up to 5 years ]Assess overall survival (OS).
- Overall response rate [ Time Frame: Up to 5 years ]Assess overall response rate.
- Response rate by CA19-9 [ Time Frame: An average of 1 year ]Assess response rate as measured by serial CA19-9 determinations.
- Response rate by RECIST criteria 1.1 [ Time Frame: Assessment approximately every 8 weeks during treatment up to 5 years ]Assess response rate as measured by RECIST criteria 1.1 radiographic criteria.
- Ability to achieve R0 (complete) [ Time Frame: At time of surgery, approximately 6 months after enrollment ]Assess the ability to achieve R0 (complete) resection rate in anatomically appropriate patients.
- Local disease control rate. [ Time Frame: Baseline, and approximately every 8 weeks during treatment. Up to 5 years ]Measure the local disease control rate.
- Pattern of disease recurrence [ Time Frame: Up to 5 years ]Observe the pattern of disease recurrence (both in anatomic space and time) in the above patient population.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703089
|Contact: Vincent J Picozzi, MD||206-223-6193||Vincent.Picozzi@virginiamason.org|
|United States, Washington|
|Virginia mason medical Center||Recruiting|
|Seattle, Washington, United States, 98101|
|Contact: Vincent J Picozzi, MD 206-223-6193 Vincent.Picozzi@virginiamason.org|
|Principal Investigator: Vincent J Picozzi, MD|
|Principal Investigator:||Vincent J Picozzi, MD||Virginia mason medical Center|