Clinical Trials Directory

Trials / Completed

CompletedNCT00331682

Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer

An Open-Label, Non-Randomized Phase II Study of Alvocidib (Flavopiridol) in Combination With Docetaxel in Refractory, Metastatic Pancreatic Cancer (NCI #6366)

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
10 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGalvocidibGiven IV
DRUGdocetaxelGiven IV

Timeline

Start date
2006-03-01
Primary completion
2008-05-01
Completion
2008-05-01
First posted
2006-05-31
Last updated
2014-05-28
Results posted
2014-01-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00331682. Inclusion in this directory is not an endorsement.