Metastatic Gastrointestinal Carcinoid Tumor Clinical Trial
Official title:
A Phase II Study of CCI-779 in Metastatic Neuroendocrine Carcinomas
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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