Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
With
Cold Spring Harbor Laboratory
Weizmann Institute of Science
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Two Stage Study Of Single Dose PEGPH20 And Cetuximab In Patients With Pancreatic Adenocarcinoma Prior To Surgical Resection
