Capecitabine and Temozolomide for Neuroendocrine Cancers
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. Secondary objectives include determining the overall and one year survival rates to this regimen, to determine progression free survival, to assess toxicities, improvement of quality of life, biochemical responses of tumor markers, and relief from NET symptoms.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Capecitabine and Temozolomide for Progressive, Differentiated, Metastatic Neuroendocrine Cancers|
- Time to response [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2005|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Capecitabine and Temozolomide
Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).
Drug: Capecitabine and temozolomide
Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Temozolomide 150-200 mg/m2/day (PO divided BID) Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
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|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Robert L Fine, MD||Columbia University|