Two Stage Study Of Single Dose PEGPH20 And Cetuximab In Patients With Pancreatic Adenocarcinoma Prior To Surgical Resection
This study has several purposes. DCE-MRI will be used to image the tumor. Safety of cetuximab given before surgery will be studied. Cetuximab delivery to the tumor will be studied. In Stage 2 of this study, the safety of cetuximab and PEGPH20 given before surgery will be studied. Also, the effects of PEGPH20 on tumors will be studied.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Two Stage Study Of Single Dose PEGPH20 And Cetuximab In Patients With Pancreatic Adenocarcinoma Prior To Surgical Resection|
- effects of PEGPH20 [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]in close proximity to surgical resection of pancreatic adenocarcinoma. Safety with regards to operative and post-operative complications will be characterized.
|Study Start Date:||September 2014|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: PEGPH20 And Cetuximab
5 participants will be consented to undergo DW- & DCE-MRI for sequence parameter optimization. The 1st stage of the study, patients (n = 5) will undergo (DW-) & (DCE)-MRI for repeatability investigation & T1 mapping. 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 undergo DW- & (DCE)-MRI. 1 to 3 days later, patients will receive 1 IV dose of PEGPH20 at 3 μg/kg/10 min. 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. Blood samples will be drawn at various time points.
|Drug: PEGPH20 Drug: Cetuximab Device: DW & DCE-MRI|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02241187
|Contact: Kenneth Yu, MD MSc||646-888-4188|
|Contact: Eileen O'Reilly,, MD||646-888-4182|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Kenneth Yu, M.D., M.Sc. 646-888-4188|
|Contact: Eileen O'Reilly, MD 646-888-4182|
|Principal Investigator: Kenneth Yu, MD|
|Principal Investigator: Eileen O'Reilly, MD|
|Principal Investigator: Ronald DeMatteo, MD|
|Principal Investigator:||Kenneth Yu, MD MSc||Memorial Sloan-Kettering Cancer Center|