Tissue Pharmacokinetics of Intraoperative Gemcitabine in Resectable Adenocarcinoma of the Pancreas

Phase 0 Terminated 18 enrolled M.D. Anderson Cancer Center

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn if gemcitabine can enter pancreas cancer cells, to measure the amount of it that may enter the cells, and for biomarker testing. Biomarkers may be related to participant's reaction to the study drug.

Timeline

Start: 2011-01
Primary completion: 2019-04-19
Completion: 2019-04-19

Outcome

Outcome not reported

Stopped: “Per memo from study team”

Publications

Koay EJ, Truty MJ, Cristini V, Thomas RM, Chen R, Chatterjee D, Kang Y, Bhosale PR, Tamm EP, Crane CH, Javle M, Katz MH, Gottumukkala VN, Rozner MA, Shen H, Lee JE, Wang H, Chen Y, Plunkett W, Abbruzzese JL, Wolff RA, Varadhachary GR, Ferrari M, Fleming JB. Transport properties of pancreatic cancer describe gemcitabine delivery and response. J Clin Invest. 2014 Apr;124(4):1525-36. doi: 10.1172/JCI73455. Epub 2014 Mar 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	Losartan	Other / unclassified	50 mg	Oral
Subject	Losartan	Other / unclassified	100 mg	Oral