Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer
The primary objective is to determine the maximum tolerated dose (MTD) of azacitidine and gemcitabine in subjects with previously untreated and unresectable pancreatic cancer. Also to determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer|
- Determine maximum tolerated dose [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]There will be 5 planned cohorts that will receive the escalating doses of azicitidine and gemcitabine. There will be at least 3 patients in each cohort
- Toxicity [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]To describe the toxicity associated with the use of this combination regimen
- Determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells [ Time Frame: unknown ] [ Designated as safety issue: No ]Perform multivariable regression models to explore and assess associations among changes in DNA methylation in peripheral blood cells, chemo effect on tumor (stable disease or shrinkage based on scans) and changes in tumor markers.
|Study Start Date:||July 2010|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Vidaza will be administered subq daily for 5 consecutive days each 28-day cycle
Other Name: Azacitibine
This is a Phase I single arm study designed for subjects with newly diagnosed, unresectable pancreatic cancer who have received no prior chemotherapy, radiation therapy, or surgery with curative intent for pancreatic cancer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167816
|United States, Oklahoma|
|Stephenson Cancer Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Osama Qubaiah, MD||University of Oklahoma|