Clinical trialPhase 1Unknown
Gemcitabine & Nab-Paclitaxel in Pancreatic Adenocarcinoma With Positive Peritoneal Cytology
Gemcitabine and Nab-Paclitaxel in Pancreatic Adenocarcinoma With Positive Peritoneal Cytology as a Sole Metastatic Site, a Pilot Study
- Outcome
- Outcome unknown
- Phase
- Phase 1
- Status
- Unknown
- Study type
- Interventional
- Start
- 1 May 2018
- Expected end
- 1 May 2023
- Enrollment
- 21 participants
- Sites
- 1
- Primary outcomes
- Frequency of cytological conversion
- Sponsor
- Other
- Results posted
- No
- Last update
- 21 July 2021
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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.