Phase II Trial of CCI-779 in Locally Advanced or Metastatic Pancreatic Cancer
I. Determine the overall survival at 6 months in patients with locally advanced or
metastatic pancreatic cancer treated with CCI-779.
I. Determine time to progression, progression-free survival, overall survival, and tumor
response rate in patients with measurable disease treated with this drug.
II. Correlate biomarkers of response with clinical response in patients treated with this
III. Determine the safety and toxicity of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the
absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival (OS)
The method of Thall and Simon will be employed.
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M D Anderson Cancer Center||Houston, Texas 77030|