WithdrawnPhase 1

Veliparib, Capecitabine, and Temozolomide in Patients With Advanced, Metastatic, and Recurrent Neuroendocrine Tumor

Stopped: Loss of funding support

0Started 2017-12

Plain-language summary

This phase I trial studies the side effects and best dose of veliparib when given together with capecitabine and temozolomide in treating patients with neuroendocrine tumor that has spread to other places in the body and usually cannot be cured or controlled with treatment, has returned after a period of improvement, and cannot be removed by surgery. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pathologically confirmed metastatic unresectable well differentiated (low grade and intermediate grade) neuroendocrine tumors (Ki-67 \< 20% and mitotic rate \< 2 per 10 high power field) that demonstrate progressive disease (by serial computed tomography \[CT\] or magnetic resonance imaging \[MRI\] scans) in past 12 months including * Carcinoid tumors originating anywhere in the body including the gastrointestinal (GI) tract or bronchial tree or thymus * Pancreatic neuroendocrine tumors (including functional and non-functional islet cell, insulinomas and glucagonomas) * Pheochromocytomas * Gastrinomas (Zollinger-Ellison syndrome) * Multiple endocrine neoplasia (MEN type I/II), * Adrenal carcinomas with NET markers by immunohistochemistry (IHC) or serum * Somatostatinoma * VIPoma (vasoactive intestinal peptide) * Merkel cell tumors * Medullary thyroid carcinoma * Neuroendocrine tumors of unknown primary site * Patients must have progressed on octreotide therapy and/or radioactive isotopes linked to octreotide or its congeners if they had a positive octreotide scan; patients who have negative or mildly positive octreotide scans are exempt from this requirement * Somatostatin analogs can be continued at their tolerated dose in patients with functional symptoms related to underlying disease such as in functional islet cell, insulinomas, glucagonomas etc * Patients may have received prior chemotherapy for advanced disease including eit…

What they're measuring

Maximum tolerated dose determined by dose limiting toxicities defined as any toxicity in the first course evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Timeframe: Up to 28 days

Trial details

NCT IDNCT02831179

SponsorVanderbilt-Ingram Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02