Gemcitabine Pharmacokinetics After Preoperative Chemoradiation Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01938716|
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : June 12, 2019
The goal of this clinical research study is to learn if gemcitabine given during surgery can enter pancreas cancer cells in patients who have already received chemotherapy and radiation.
Gemcitabine is a drug used to treat pancreatic cancer. However, it has not previously been studied if gemcitabine can enter pancreatic cancer cells. Gemcitabine is designed to block the growth of cancer cells, which may cause cancer cells to die.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Gemcitabine||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Tissue Pharmacokinetics of Intraoperative Gemcitabine in Adenocarcinoma of the Pancreas After Preoperative Chemoradiation Therapy|
|Actual Study Start Date :||March 2012|
|Actual Primary Completion Date :||June 3, 2019|
|Actual Study Completion Date :||June 3, 2019|
Experimental: Gemcitabine Infusion
Gemcitabine administered intravenously as a dose of 500 mg/m2 at a fixed dose rate of 10 mg/m2/min for the first 5 patients (to validate hematologic safety). Next 15 subsequent patients receive 750 mg/m2 at a fixed dose rate of 10 mg/m2/min. The drug infusion started 50-75 minutes prior to complete gross tumor removal (timing dependent on dose) in order to have drug administration complete at tumor removal.
500 mg/m2 at a fixed dose rate of 10 mg/m2/min by vein for the first 5 patients during pancreatic surgery. Next 15 subsequent patients receive 750 mg/m2 by vein at a fixed dose rate of 10 mg/m2/min.
- Intratumoral Gemcitabine Levels in Human Pancreatic Cancer Tissue After a Single Intraoperative Infusion [ Time Frame: 1 day ]Quantification of serum, PBMC, and cancer tissue levels of gemcitabine from frozen samples assessed using standardized techniques in high performance liquid chromatography-mass spectrometry. Blood vessels in resected tumors detected by immunohistochemistry (IHC) using antibodies to CD31 or vWF. The mRNA and protein expression of SHH, Gli and SMO measured by RT-PCR and IHC method. Range of levels in patients with PC established. These markers correlated to the gemcitabine levels measured in the cancerous tissue. The expression level of genes involved in gemcitabine metabolism in the resected primary tumors examined. The mRNA level measured using real time PCR and protein expression by IHC. Gene expression level correlated to the gemcitabine measurements. Markers of proliferation and apoptosis measured by p21 and Ki67 IHC and fluorescent TUNEL analysis.
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): NCT01938716
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gauri Varadhachary, MD, MBBS||M.D. Anderson Cancer Center|