NCT00093782

Temsirolimus in Treating Patients With Metastatic Neuroendocrine Carcinoma

A Phase II Study of CCI-779 in Metastatic Neuroendocrine Carcinomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well CCI-779 works in treating patients with progressive metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die.

Detailed description

OBJECTIVES: I. To assess the objective tumor response rate (i.e. partial or complete responses as defined by the RECIST criteria) in patients with progressive metastatic neuroendocrine tumours given CCI-779. II. To assess the stable disease rate and duration, time to progression, median survival time, 1-year survival rate and toxicity in patients with metastatic neuroendocrine carcinomas given CCI-779. As of 19 July 2010, overall survival follow-up is to be discontinued for the four remaining patients on long term follow-up. At that point in time, these patients had been off-treatment for 3 to 5 years. Time to progression and median survival times will be based on the currently available data. III. To measure baseline levels of various elements up- and downstream of the mammalian target of rapamycin (mTOR). Where post-treatment biopsies are available, they will be analyzed for suppression of elements in the mTOR pathway as well as for any effect on cell cycle progression, apoptosis or anti-angiogenic effects. OUTLINE: This is an open-label, multicenter study. Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or partial response (PR) receive 2 additional courses beyond CR or PR. Patients are followed up for survival.

Conditions

• Metastatic Gastrointestinal Carcinoid Tumor
• Pulmonary Carcinoid Tumor
• Recurrent Gastrointestinal Carcinoid Tumor
• Recurrent Islet Cell Carcinoma

Interventions

Type	Name	Description
DRUG	temsirolimus	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2003-12-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2004-10-08
• Last updated: 2017-02-07
• Results posted: 2016-12-12

Locations

1 site across 1 country: Canada