Two Stage Study Of Single Dose PEGPH20 And Cetuximab In Patients With Pancreatic Adenocarcinoma Prior To Surgical Resection
NCT ID: NCT02241187
Last Updated: 2017-09-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
2 participants
INTERVENTIONAL
2014-09-12
2016-09-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
PEGPH20
Cetuximab
DW & DCE-MRI
blood draws
Blood samples will be drawn at various time points.
Interventions
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PEGPH20
Cetuximab
DW & DCE-MRI
blood draws
Blood samples will be drawn at various time points.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Cold Spring Harbor Laboratory
OTHER
Weizmann Institute of Science
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Kenneth Yu, MD MSc
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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14-039
Identifier Type: -
Identifier Source: org_study_id