Molecular Analysis in Tissue Samples From Patients With Advanced or Metastatic Neuroendocrine Tumors
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ClinicalTrials.gov Identifier: NCT02092714 |
Recruitment Status :
Active, not recruiting
First Posted : March 20, 2014
Last Update Posted : July 23, 2019
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Tracking Information | ||||
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First Submitted Date | March 18, 2014 | |||
First Posted Date | March 20, 2014 | |||
Last Update Posted Date | July 23, 2019 | |||
Actual Study Start Date | October 16, 2013 | |||
Actual Primary Completion Date | April 11, 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Feasibility, defined as the true proportion of patients whose CancerCode sequencing results in the identification of at least 1 actionable mutation [ Time Frame: Up to 3 years ] | |||
Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT02092714 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | |||
Descriptive Information | ||||
Brief Title | Molecular Analysis in Tissue Samples From Patients With Advanced or Metastatic Neuroendocrine Tumors | |||
Official Title | A Pilot Study Utilizing Molecular Analysis Via Cancer CodeTM to Identify Therapeutic Targets for Patients With Advanced Neuroendocrine Tumors | |||
Brief Summary | This pilot research trial studies molecular analysis in tissue samples from patients with advanced or metastatic neuroendocrine tumors. Studying samples of tissue from patients with neuroendocrine tumors in the lab may help doctors identify mutations to classify disease and plan the best treatment. | |||
Detailed Description | PRIMARY OBJECTIVES: I. To perform gene panel sequencing of patients with neuroendocrine tumors under care at Fox Chase Cancer Center for the purpose of identifying therapeutic targets and prognostic markers. II. To assess the feasibility of performing a clinical trial of molecularly matched therapy in patients with differing subtypes of neuroendocrine tumors (neuroendocrine tumors of the pancreas [PNETs], non-pancreatic neuroendocrine tumors [NETs], and poorly differentiated NETs), based upon the proportion of patients with actionable mutations. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients whose therapy is altered based upon the results of molecular testing. II. To evaluate the percent of patients for which a local protocol offers a potential therapeutic option. III. To evaluate the number of patients who are treated based on therapy guided by molecular profiling. TERTIARY OBJECTIVES: I. To compare the outcomes of patients treated with early therapy based on gene profiling with the outcomes of those treated via National Cancer National Comprehensive Cancer Network (NCCN) guideline recommended therapies (systemic therapy, liver directed therapy, hepatic resection) or expectant observation via measurement of progression free survival (PFS), via radiographic response rates, and via biochemical response rate. II. To evaluate the prognostic power of commonly (>= 10%) detected mutations. III. To evaluate the impact of mammalian target of rapamycin (mTOR) pathway alterations (mutations of phosphatase and tensin homolog gene [PTEN], phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha [PIK3CA]) on efficacy of mTOR targeted therapeutics, as assessed by progression free survival (PFS) and response rate (RR). IV. To evaluate the impact of o-6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) status on the efficacy of an alkylating based chemotherapy regimen (Temodar, dacarbazine, streptozocin), as assessed by progression free survival (PFS) and response rate (RR). V. To evaluate the impact of thymidine phosphorylase (TP) status on the efficacy of a fluoropyrimidine-based chemotherapy regimen (capecitabine, 5-fluorouracil), as assessed by progression free survival (PFS) and response rate (RR). VI. To evaluate the impact of excision repair cross-complementing 1 (ERCC-1) status on the efficacy of a platinum-based chemotherapy regimen (carboplatin, cisplatin, oxaliplatin), as assessed by progression free survival (PFS) and response rate (RR). OUTLINE: Previously collected tissue samples are analyzed via mutational sequencing and immunohistochemistry. After completion of study, patients are followed for up every 3-6 months for 3 years. |
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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: blood and tumor tissue
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Sampling Method | Non-Probability Sample | |||
Study Population | Patients with incurable neuroendocrine tumors, excluding small cell/large cell lung cancers and Merkel cell carcinomas | |||
Condition | Neuroendocrine Tumor | |||
Intervention | Other: laboratory biomarker analysis
Correlative studies
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Study Groups/Cohorts | Ancillary-correlative (molecular analysis)
Previously collected tissue samples are analyzed via mutational sequencing and immunohistochemistry.
Intervention: Other: laboratory biomarker analysis
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Active, not recruiting | |||
Estimated Enrollment |
90 | |||
Original Estimated Enrollment | Same as current | |||
Estimated Study Completion Date | November 16, 2020 | |||
Actual Primary Completion Date | April 11, 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT02092714 | |||
Other Study ID Numbers | CGI-061 NCI-2013-01950 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 13-040 ( Other Identifier: Fox Chase Cancer Center ) P30CA006927 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Fox Chase Cancer Center | |||
Study Sponsor | Fox Chase Cancer Center | |||
Collaborators | National Cancer Institute (NCI) | |||
Investigators |
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PRS Account | Fox Chase Cancer Center | |||
Verification Date | July 2019 |