Clinical Trial: Capecitabine and Temozolomide for Neuroendocrine Cancers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Study of Capecitabine and Temozolomide for Progressive, Differentiated, Metastatic Neuroendocrine Cancers

Brief 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.

Detailed Summary:

Neuroendocrine tumor (NET) is a classification that has evolved over time to include a group of related tumors which all originate from neuroendocrine cells. This group includes carcinoid tumors, pancreatic endocrine tumors (PETs), catecholamine-secreting tumors (e.g. pheochromocytomas), medullary carcinoma of the thyroid and small cell lung cancer. Carcinoid tumors are mostly derived from serotonin-producing enterochromaffin cells, occuring most frequently in the gastrointestinal tract (67.5%) and the bronchopulmonary system (25.3%). Pancreatic endocrine tumors (PETs) arise from the several types of pancreatic islet cells, which manifest as insulinomas, somatostatinomas or glucagonomas. NETs are broadly classified as functional or nonfunctional, as determined by whether plasma hormone elevation and endocrine symptoms occur. NETs are classified into two groups: 1) rapidly growing anaplastic small cell cancers such as small cell lung cancer and small cell carcinomas of the GI tract and 2) slow growing, more differentiated NETs such as carcinoid and PET.

In total, an estimated 12,000 - 15,000 cases of NETs (not counting small cell carcinomas) are diagnosed in the United States annually. The incidence of carcinoid tumors alone is estimated to be 2 per 100,000 in the United States (5,400 cases/yr/U.S.). PETs are less common, with about 1,000 new cases per year in the United States. Carcinoids and PETs are potentially curable by surgical resection; the 5-year survival rates in patients with localized carcinoid is 78.2%. However, these tumors are frequently indolent in their growth and patients often present with unresectable or metastatic disease (80% of all cases). The hormonal symptoms that may accompany their disease, as exemplified by carcinoid syndrome, complicate the management of these patients. Hormonal therapy, namely octreotide, is used to relieve symptoms and has be
Sponsor: Columbia University

Current Primary Outcome:

  • Number of Participants With Partial Response (PR) [ Time Frame: 12 months ]
    PR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as a reduction of ≥ 30% in the sum of the longest diameter for all target lesions lasting > 4 weeks, during which no new lesions may appear, when compared with with pretreatment measurements.
  • Number of Participants With Complete Response (CR) [ Time Frame: 12 months ]
    CR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as disappearance of all target lesions (primary and metastases), signs, symptoms, and biochemical changes related to the tumor for >4 weeks, during which no new lesions may appear and no existing lesion may enlarge.


Original Primary Outcome: Time to response [ Time Frame: 12 months ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Columbia University

Dates:
Date Received: March 23, 2009
Date Started: August 2005
Date Completion:
Last Updated: June 22, 2016
Last Verified: June 2016