Pancreatic Neuroendocrine Cancer Clinical Trial
Official title:
A Pilot Study to Identify Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors
NCT number | NCT01603004 |
Other study ID # | 12-058 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 14, 2012 |
Est. completion date | June 24, 2019 |
Verified date | June 2019 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Sunitinib and everolimus are two new treatments approved in 2011 for patients with pancreatic neuroendocrine tumors (NETs). In addition, some traditional chemotherapies are often used to treat pancreatic NETs. 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.
Status | Completed |
Enrollment | 25 |
Est. completion date | June 24, 2019 |
Est. primary completion date | June 24, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histopathologic evidence of well differentiated pancreatic NET - Evidence of measurable disease by RECIST 1.1. 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 everolimus ,sunitinib or traditional cytotoxic 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: - Patient has a history of a second active malignancy with evidence of metastases. Patients with a history of resected prior malignancy 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. |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival | standard MRI sequences will be performed, according to guidelines from RECIST 1.1. | 2 years | |
Secondary | Overall survival | standard MRI sequences will be performed, according to guidelines from RECIST 1.1. | 5 years | |
Secondary | best response | standard MRI sequences will be performed, according to guidelines from RECIST 1.1. | 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02806648 -
A Trial to Assess the Activity and Safety of Palbociclib in Patients With Well and Moderately Differentiated Metastatic Pancreatic Neuroendocrine Tumors (pNET)
|
Phase 2 |