Clinical trialPhase 1Unknown
Alternative Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer
Alternating Neoadjuvant Gemcitabine-Nab-Paclitaxel and Nanoliposomal Irinotecan (Nal-IRI) With 5-Fluorouracil and Folinic Acid (Leucovorin) Regimens in Resectable and Borderline Resectable Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 1
- Status
- Unknown
- Study type
- Interventional
- Start
- 17 September 2018
- Expected end
- 17 September 2022
- Enrollment
- 30 participants
- Sites
- 1
- Primary outcomes
- Treatment safety as assessed by CTCAE v4.03
- Sponsor
- Other
- Results posted
- No
- Last update
- 27 January 2021
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Brief summary public domain (ClinicalTrials.gov)
Using alternative neoadjuvant gemcitabine-nab-paclitaxel and nal-IRI with 5-Fluorouracil (5FU) and folinic acid (Leucovorin) regimens of localized cancer, we hope to ensure exposure of the cancer to a broader array of potentially active agents. Also, potentially improves patient tolerance and minimizes significant drug toxicity that could impair delivery of all treatment elements. Furthermore, it may enable prediction of superior to inferior treatment outcomes at an earlier point in the disease progress.
Detailed description public domain (ClinicalTrials.gov)
This research study is a Phase Ib clinical trial. It will assess the Safety, tolerability, and feasibility of gemcitabine-nab paclitaxel alternating with nal-IRI/5FU/leucovorin (NAPOLI) in de novo resectable and borderline resectable pancreatic cancer. Subjects must have a newly diagnosed resectable or borderline resectable pancreatic ductal cancer 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 with NAPOLI will be administered on days 1 and 15.