NCT02092714

Molecular Analysis in Tissue Samples From Patients With Advanced or Metastatic Neuroendocrine Tumors

A Pilot Study Utilizing Molecular Analysis Via Cancer CodeTM to Identify Therapeutic Targets for Patients With Advanced Neuroendocrine Tumors

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuroendocrine Tumor

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2013-10-16
• Primary completion: 2018-04-11
• Completion: 2020-11-16
• First posted: 2014-03-20
• Last updated: 2019-07-23

Locations

1 site across 1 country: United States