Capecitabine and Temozolomide for Neuroendocrine Cancers (NCT00869050) | Clinical Trial Compass
CompletedPhase 2
Capecitabine and Temozolomide for Neuroendocrine Cancers
United States41 participantsStarted 2005-08
Plain-language summary
This phase II study is designed to assess whether treatment with capecitabine/temozolomide (CAP/TEM) is safe and effective in treating subjects with progressive, differentiated, metastatic neuroendocrine tumors (NET). The primary objective of the study is to determine the radiologic response rate to this regimen in progressive, metastatic, differentiated neuroendocrine cancers.
Who can participate
Age range18 Years ā 80 Years
SexALL
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Inclusion Criteria:
* Patients must have a tissue diagnosis of any of the following metastatic, well or moderately differentiated, slow growing neuroendocrine tumor and must demonstrate progressive metastatic disease by prior serial computerized tomography (CT) or magnetic resonance imaging (MRI) scans, or have increased symptoms from their tumors while on sandostatin LAR or octreotide.
* Carcinoid tumors originating anywhere in the body including the gastrointestinal (GI) tract or bronchial tree
* 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, paragangliomas, adrenal carcinomas with NET markers by immunohistochemistry (IHC) or serum.
* Somatostatinoma, VIPoma, Merkel Cell tumors, medullary thyroid carcinoma
* Neuroendocrine tumors of unknown primary site
* Any other tumors with differentiated neuroendocrine features may be included such as aggressive pituitary adenomas/carcinomas, which are neuroendocrine in origin
* Patients must have progressed on octreotide therapy (up to and including Sandostatin LAR-60 mg/month) and/or radioactive isotopes linked to octreotide or its congeners if they has a positive octreotide scan. Patients who have negative or mildly positive octreotide scans are exempt from this requirement. Exceptions to this requirement are patients who have NETs in the pituitary gland. Saā¦
What they're measuring
1
Number of Participants With Partial Response (PR)
Timeframe: 12 months
2
Number of Participants With Complete Response (CR)