Everolimus in Patients With Pancreatic Neuroendocrine Tumors Metastatic to the Liver Previously T… (NCT02031536) | Clinical Trial Compass
TerminatedPhase 2
Everolimus in Patients With Pancreatic Neuroendocrine Tumors Metastatic to the Liver Previously Treated With Surgery
Stopped: Slow accrual
United States2 participantsStarted 2014-04-10
Plain-language summary
This randomized phase II trial studies how well everolimus works in treating patients with pancreatic neuroendocrine tumors metastatic to the liver previously treated with surgery. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving everolimus after surgery may kill any tumors cells that remain.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA:
* Patients must have histologically or pathologically confirmed metastatic low or intermediate grade pancreatic neuroendocrine tumor(s) to the liver as per the Klimstra guidelines
* Patients must have recovered from an R0 or R1 resection of all disease (including resection of a primary primitive neuroectodermal tumor \[PNET\] if present); patients may have had resection plus microwave or radiofrequency ablation, provided that no ablated lesion was \>= 5 cm prior to ablation
* Patients must be within 4 to 8 weeks from the completion of surgery at time of randomization
* Patients must have paraffin-embedded fixed metastatic tumor tissue available for submission for central review; core biopsy or surgical specimens required
* Patients must have post-operative computed tomography (CT) or magnetic resonance imaging (MRI) prior to randomization and =\< 4 weeks after completion of surgery to confirm disease status; patients must be able to tolerate CT or MRI imaging including contrast agents as required for the protocol
* Women of child-bearing potential and sexually active males must be strongly advised to use an accepted and highly effective method of contraception or abstain from sexual intercourse for the duration of their treatment through 8 weeks after their last dose of protocol therapy; women of child-bearing potential, sexually active males, and the female partners of male participants should be advised of the risk of becoming pregnant or fathering a ch…
What they're measuring
1
Disease Free Survival (DFS)
Timeframe: assessed every 12 weeks while on treatment and then every 3 months if < 2 years from study entry; every 6 months up to 5 years from study entry or recurrence, whichever occurred first