Stage IV Pancreatic Cancer Clinical Trial
Official title:
An Open-Label, Non-Randomized Phase II Study of Alvocidib (Flavopiridol) in Combination With Docetaxel in Refractory, Metastatic Pancreatic Cancer (NCI #6366)
Drugs used in chemotherapy, such as docetaxel and flavopiridol, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Flavopiridol may also help docetaxel work better by making tumor cells more sensitive to the drug. This phase II trial is studying how well giving docetaxel followed by flavopiridol works in treating patients with refractory metastatic pancreatic cancer.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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