An Open-Label, Non-Randomized Phase II Study of Alvocidib (Flavopiridol) in Combination With Docetaxel in Refractory, Metastatic Pancreatic Cancer (NCI #6366)
PRIMARY OBJECTIVES:
I. Determine the response rate in patients with refractory, metastatic pancreatic cancer
treated with weekly, sequential docetaxel and flavopiridol.
SECONDARY OBJECTIVES:
I. Determine the time to progression and overall survival of patients treated with this
regimen.
II. Assess the toxicity of this regimen.
OUTLINE: This is a non-randomized, open-label, prospective study.
Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV
over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate as measured by RECIST criteria
Up to 2 years
No
Eileen O'Reilly
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
NCI-2012-01471
NCT00331682
March 2006
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |