Potential Imaging and Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01603004
First received: May 16, 2012
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

Sunitinib and everolimus are two new treatments approved in 2011 for patients with pancreatic neuroendocrine tumor (pNET). In addition, some traditional chemotherapies are often used to treat pNETs. Traditional chemotherapy is also known as "cytotoxic therapy" and works by killing cells that are actively dividing. There have been no studies to compare the different types of treatment. Since the patient is eligible for treatment with either sunitinib , everolimus or traditional chemotherapy it can help us identify factors that may help future patients benefit from these therapies.

The investigators routinely monitor the progress of the treatment with magnetic resonance imaging (MRI) scans to measure how pNET tumors change in size over time. MRI can also measure how water moves within tumors, which is another way to measure how tumors respond to treatment. In this study, the investigators will look at the MRI characteristics of tumors in the liver as the patient undergoes treatment, to help us identify changes on MRI that may best predict a benefit to sunitinib, everolimus or traditional chemotherapy treatment.


Condition Intervention
Pancreatic Neuroendocrine Cancer
Other: MRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study to Identify Potential Imaging and Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    standard MRI sequences will be performed, according to guidelines from RECIST 1.1.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    standard MRI sequences will be performed, according to guidelines from RECIST 1.1.

  • best response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    standard MRI sequences will be performed, according to guidelines from RECIST 1.1.


Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
sunitinib , everolimus or traditional chemotherapy
A total of 30 patients with well differentiated pancreatic NET who have known liver metastases and who are planned to initiate therapy with either targeted sunitinib or everolimus or traditional cytotoxic chemotherapy will be recruited for this study. We plan to recruit approximately 10 patients for each therapy. Evidence of metastatic disease will be determined at the discretion of the oncologist based on available imaging, surgical and pathologic evidence.
Other: MRI
Patients will be treated with sunitinib, everolimus or traditional chemotherapy according to standard of care. All patients will undergo routine follow-up MRI at approximately three months intervals. ADC of liver metastases at baseline will be compared to ADC at each follow-up MRI. In addition, a research MRI will be obtained at 2 weeks following initiation of treatment, when patients are scheduled for a clinical follow-up with their oncologists. Occasionally, patients will not be able to obtain the research MRI at exactly 2 weeks, due to scheduling constraints. A first follow-up research MRI between 1 and 3 weeks will be considered acceptable for analysis. The research MRI will be otherwise identical to the clinical MRI, which include DWI sequences. The rationale for these studies is to determine if DWI can detect changes in tumor cellularity by measuring water diffusion and serve as an early predictor for response to drug therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Potential research patients will be identified by doctors from the Gastrointestinal Oncology Service in the Department of Medicine.

Criteria

Inclusion Criteria:

  • Histopathologic evidence of well differentiated pancreatic neuroendocrine tumor
  • Evidence of metastatic disease of at least 2.0 cm in the liver by prior MRI or CT imaging. Both patients with synchronous disease and those with prior resected primary cancers will be eligible.
  • Patient ≥18 years of age on the day of signing informed consent.
  • Planned initiation of active therapy with either everolimus ,sunitinib or traditional chemotherapy.

Patients can be included in this study, regardless of prior therapy, but cannot undergo concurrent therapy, such as hepatic artery embolization

  • Available archival tissue with adequate FFPE tissue for analysis verified by a pathologist (in cases of biopsies less than 2 cm and/or less than 70% tumor content 10 slides will be required for adequate DNA preparation. For larger biopsies and any resections, 5 slides are sufficient for DNA extraction).

Exclusion Criteria:

  • Any contraindication to MRI based on departmental MR questionnaire
  • Inability to cooperate for an MR exam
  • Patient has a history of a second active malignancy with evidence of metastases. Patients with a history of resected prior malignancy or one that would not interfere with the MRI results are allowed.
  • Patient has known psychiatric or substance abuse disorders that would, in the opinion of the treating investigator, interfere with cooperation with the requirements of the trial.
  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: NCT01603004

Contacts
Contact: Diane Reidy-Lagunes, MD 646-888-4185
Contact: Kinh Gian Do, MD, Phd 212-639-8591

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Diane Reidy-Lagunes, MD    646-888-4185      
Contact: Kinh Gian Do, MD, PhD    212-639-8591      
Principal Investigator: Diane Reidy-Lagunes, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Diane Reidy-Lagunes, M.D Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01603004     History of Changes
Other Study ID Numbers: 12-058
Study First Received: May 16, 2012
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
MRI
12-058

Additional relevant MeSH terms:
Adenoma, Islet Cell
Neuroendocrine Tumors
Adenoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Pancreatic Diseases
Pancreatic Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014