Potential Imaging and Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors
This study is currently recruiting participants.
Verified November 2012 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01603004
First received: May 16, 2012
Last updated: November 20, 2012
Last verified: November 2012
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Purpose
Sunitinib and everolimus are two new treatments approved in 2011 for patients with pancreatic neuroendocrine tumor (pNET). Since the patient is eligible for treatment with either sunitinib or everolimus, it can help us identify factors that may help future patients benefit from these two 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 or everolimus 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: | 20 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
pancreatic net pt treated with sunitinib or everolimus
A total of 20 patients with well differentiated pancreatic NET who have known liver metastases and who are planned to initiate therapy with either sunitinib or everolimus 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 or everolimus 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. 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 or sunitinib. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603004
Contacts
| Contact: Kinh Gian Do, M.D., Ph.D. | 212-639-8591 | |
| Contact: Diane Reidy-Lagunes, MD | 646-888-4185 |
Locations
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Kinh Gian Do, MD, PhD 212-639-8591 | |
| Contact: Diane Reidy-Lagunes, MD 646-888-4185 | |
| Principal Investigator: Kinh Gian Do, MD, PhD | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Kinh Gian Do, M.D., Ph.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: | November 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
MRI 12-058 |
Additional relevant MeSH terms:
|
Neuroendocrine Tumors Adenoma, Islet Cell Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Adenoma Neoplasms, Glandular and Epithelial Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases |
Pancreatic Diseases Endocrine System Diseases Everolimus Sunitinib Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013