Two Stage Study Of Single Dose PEGPH20 And Cetuximab In Patients With Pancreatic Adenocarcinoma Prior To Surgical Resection
|ClinicalTrials.gov Identifier: NCT02241187|
Recruitment Status : Completed
First Posted : September 16, 2014
Results First Posted : September 27, 2017
Last Update Posted : September 27, 2017
|Condition or disease||Intervention/treatment|
|Pancreatic Cancer||Drug: PEGPH20 Drug: Cetuximab Device: DW & DCE-MRI Other: blood draws|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Two Stage Study Of Single Dose PEGPH20 And Cetuximab In Patients With Pancreatic Adenocarcinoma Prior To Surgical Resection|
|Actual Study Start Date :||September 12, 2014|
|Primary Completion Date :||September 13, 2016|
|Study Completion Date :||September 13, 2016|
Experimental: PEGPH20 And Cetuximab
5 participants will undergo DW- & DCE-MRI for sequence parameter optimization. The 1st stage of the study, patients (n = 5) will have the option to undergo (DW-) & (DCE)-MRI for repeatability investigation & T1 mapping. Optional DW- & DCE-MRI will be repeated 2 to 5 days later, followed shortly by administration of 1 intravenous dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later.Blood samples will be drawn at various time points. The resected tumor specimen will be studied. If deemed safe, we will proceed to the second stage of the study. Patients (n = 5) will have the option to undergo DW- & DCE-MRI. 1 to 3 days later, patients will receive 1 IV dose of PEGPH20 at 3 μg/kg/10 min. Optional DW- & DCE-MRI will be repeated 1 to 2 days after PEGPH20 administration, followed on that day by administration of 1 IV dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later.
Device: DW & DCE-MRI
Other: blood draws
Blood samples will be drawn at various time points.
- Effects of PEGPH20 [ Time Frame: 1 year ]administration on resectable pancreatic adenocarcinoma tumors. DW- and DCE-MRI and distribution of cetuximab will be used to study tumor permeability to small and larger molecules, respectively. Resected tumors will be carefully studied for evidence of stromal degradation.
- Safety of Administration of PEGPH20 and Cetuximab [ Time Frame: 1 year ]in close proximity to surgical resection of pancreatic adenocarcinoma. Safety with regards to operative and post-operative complications will be characterized.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241187
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Kenneth Yu, MD MSc||Memorial Sloan Kettering Cancer Center|