Two Stage Study Of Single Dose PEGPH20 And Cetuximab In Patients With Pancreatic Adenocarcinoma Prior To Surgical Resection

Study Overview

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.

N/A

Pancreatic Cancer

DRUG: PEGPH20
DRUG: Cetuximab
DEVICE: DW & DCE-MRI
OTHER: blood draws

14-039

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-09-12	Results First Submitted 2017-07-21	Last Update Submitted that met QC Criteria 2017-09-25
First Submitted that Met QC Criteria 2014-09-12	Results First Submitted that Met QC Criteria 2017-09-25	Last Update Posted (ACTUAL) 2017-09-27
First Posted (ACTUAL) 2014-09-16	Results First Posted 2017-09-27	Last Verified 2017-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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 repe	DRUG: PEGPH20 DRUG: Cetuximab DEVICE: DW & DCE-MRI OTHER: blood draws Blood samples will be drawn at various time points.

Participant Group/Arm

Intervention/Treatment

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 repe

DRUG: PEGPH20

DRUG: Cetuximab

DEVICE: DW & DCE-MRI

OTHER: blood draws

Blood samples will be drawn at various time points.

Primary Outcome Measures	Measure Description	Time Frame
Effects of PEGPH20	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.	1 year

Secondary Outcome Measures	Measure Description	Time Frame
Safety of Administration of PEGPH20 and Cetuximab	in close proximity to surgical resection of pancreatic adenocarcinoma. Safety with regards to operative and post-operative complications will be characterized.	1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patients must have histologically or cytologically confirmed PDAC. Pathologic confirmation is mandated before initiation of any protocol specified imaging studies or drug administrations. It is recognized that for some patients, histologic or cytologic confirmation of cancer may be obtained following study enrollment. Patient volunteers to the DW- and DCE-MRI sequence parameter optimization imaging portion of the study are eligible if they have any pancreatic lesion, histologic or cytologic confirmation of pathology is not required for this patient volunteer group.
Radiographically resectable PDAC as adjudicated by MSKCC surgical oncologist without evidence of distant metastases by CT or by laparoscopy, if performed at the discretion of the surgeon.
Age > 18 years.
ECOG Performance Score of 0 - 2.
Absolute neutrophil count > 1,500 cells/mm3
Platelet count > 100,000 cells/mm3.
Adequate renal function as evidenced by serum creatinine < 1.6 mg/dL.

INR < 1.5, unless patient is on therapeutic anticoagulation where a therapeutic INR is acceptable. Anticoagulation with low molecular weight heparin or warfarin, where medically indicated, is permitted.
Patient volunteers for the DW- and DCE-MRI sequence parameter optimization portion of the study are exempt from criteria 2, 5, 6 and 8.
Women of childbearing potential must have a negative pregnancy test prior to the administration of protocol specified interventions.
Ability to understand informed consent and signing of written informed consent prior to initiation of protocol therapy.

Patients with histology other than adenocarcinoma, e.g., neuroendocrine cancer or acinar cancers, are ineligible.
No prior therapy for pancreas cancer is allowed.
Patients with metastatic or locally unresectable PDAC (resectability is as defined by MSKCC pancreatic surgeon and as outlined
Active infection, with the exception of resolving cholangitis, will preclude enrollment on the study. Preoperative interventions can only be initiated when acute cholangitis has resolved.
Patients with known hypersensitivity to any of the components of PEGPH20 or cetuximab.
For patients who choose to undergo MRI imaging, hypersensitivity to MRI IV contrast media not suitable for pre-medication.
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication).
Patients who have a history of venous or arterial thromboembolic events including pulmonary embolism, deep venous thrombosis and stroke.
Patients who are pregnant or lactating
For patients who choose to undergo MRI imaging patients who are ineligible for an MRI with contrast based on Radiology Department screening.
Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or follow up procedures.
Patient volunteers for the DW- and DCE-MRI sequence parameter optimization portion are exempt from criteria 12, 13, 14, 15, 16 and 18.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Cold Spring Harbor Laboratory
Weizmann Institute of Science

Investigators

PRINCIPAL_INVESTIGATOR: Kenneth Yu, MD MSc, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record