Trial record 2 of 6 for:    pegph20

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Cold Spring Harbor Laboratory
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02241187
First received: September 12, 2014
Last updated: NA
Last verified: September 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Pancreatic Cancer
Drug: PEGPH20
Drug: Cetuximab
Device: DW & DCE-MRI

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 10
Study Start Date: September 2014
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02241187

Contacts
Contact: Kenneth Yu, MD MSc 646-888-4188
Contact: Eileen O'Reilly,, MD 646-888-4182

Locations
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         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Cold Spring Harbor Laboratory
Investigators
Principal Investigator: Kenneth Yu, MD MSc Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02241187     History of Changes
Other Study ID Numbers: 14-039
Study First Received: September 12, 2014
Last Updated: September 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
PEGPH20
Cetuximab
14-039

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014