73
Participants
Start Date
April 19, 2005
Primary Completion Date
December 31, 2011
Study Completion Date
January 9, 2018
Docetaxel
Docetaxel 75 mg/m\^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days.
Thalidomide
Thalidomide 200 mg by mouth daily throughout the cycle.
Prednisone
Prednisone 10 mg by mouth daily throughout the cycle.
bevacizumab
Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
polymorphism analysis
Two buffy coat tubes (two 7mL blue tiger top tubes) will be obtained and wrapped in foil when the patient enters onto the study. DNA (deoxyribonucleic acid) will be isolated only for the purpose of genotype analysis of enzymes with putative relevance for docetaxel or thalidomide disposition.
immunoenzyme technique
The PBMC (peripheral blood mononuclear cells) of patients will be analyzed pre-treatment and post cycle 2 for any changes in the function of regulatory T cells. The following analysis will be performed: flow cytometry analysis, CD4 CD25 T cell enrichment, and immunosuppression assay.
laboratory biomarker analysis
Serum and urine samples will be collected at baseline and monthly to measure VEGF (vascular endothelial growth factor) levels.
pharmacological study
Plasma concentrations of docetaxel and thalidomide will be determined to assess interactions between docetaxel (and thalidomide) and the concomitant therapy.The analysis will be performed using a validated method based on liquid chromotography with mass-spectrometric detection.
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda
National Cancer Institute (NCI)
NIH