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Protocol No. UW16034

Principal Investigator Uboha, Nataliya

Phase I

Age Group Adult

Scope Local

Sponsor Type Industry; Institutional

Title Safety of TAS-102 in Combination with Temozolomide for Metastatic Pancreatic Neuroendocrine Tumors

Objective This is a clinical research trial of a drug called TAS-102 in combination with a drug called temozolomide (TMZ) for the treatment o metastatic neuroendocrine tumors. Temozolomide is currently used for the treatment of neuroendocrive tumors. TAS-102 is approved for treatment of metastatic colon cancer, but we do not know whether it is useful for the treatment of neuroendocrine tumors. The purpose of this research study is to evaluate the safety and determine the highest dose of TMZ that is safe to use in combination with TAS-102 in patients with advanced neuroendocrine tumors. We also want to look at the ability of these chemotherapy drugs to shrink or slow down the growth of metastatic pancreatic neuroendocrine tumors.

Treatment The trial consists of 2 parts. Part 1 of the trial will study what doses of the drugs are safe to use together. In order to establish the correct doses, subjects will be given different doses of the studied medications. Doses will be increased only after we know that the lower doses cause no problems to prior participants. Part 2 will further look at how these drugs are tolerated when taken together. It will also evaluate whether the studied drugs have the ability to shrink or slow down the growth of the tumors.

Description TAS-102 and TMZ are both taken my mouth.

Key Eligibility
  • Part 1: Patients with histologically or cytologically confirmed metastatic NETs of any origin of low or intermediate grade
  • Part 2: Patients with histologically confirmed unresectable or metastatic pNETs of low or intermediate grade. High-grade tumors or tumors with small cell histology will be excluded
  • Presence of measurable disease
  • Progression of disease on the most recent restaging scan or clinically significant disease at the time of evaluation justifying enrollment in a trial in the opinion of the treating physician
  • Prior chemoembolization or radiation therapy (including Y90) must be performed at least 2 weeks before study enrollment
  • Age 18 years or older
  • Women who are nursing must discontinue breast-feeding prior to the enrollment in the trial
  • Patients who have had previous treatment with TAS-102 or TMZ are ineligible
  • Patients who have had prior treatment with fluoropyrimidines (applicable to Part 1 only) are ineligible
  • Patients with a history of partial or total gastrectomy are ineligible
  • Patients who have symptomatic CNS metastases requiring treatment are ineligible
  • Patients who have had prior radiation therapy irradiating more than 10% of total bone marrow are ineligible
  • Patients who are pregnant or breast feeding are ineligible
  • Patients with known chronic infection with human immunodeficiency virus, hepatitis B, or hepatitis C are ineligible
  • Patients with ascites, pleural effusion or pericardial fluid requiring drainage in the last 4 weeks are ineligible

Applicable Disease Sites Gastrointestinal cancers, other; Lung; Pancreas; Unknown Sites

Drugs Involved TAS-102; Temodar (temozolomide); temodal (temozolomide); temozolomide

Status Open

Participating Institutions UW Hospital and Clinics