Docetaxel, Thalidomide, Prednisone, and Bevacizumab to Treat Metastatic Prostate Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

April 19, 2005

Primary Completion Date

December 31, 2011

Study Completion Date

January 9, 2018

Conditions
Prostatic Neoplasms
Interventions
DRUG

Docetaxel

Docetaxel 75 mg/m\^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days.

DRUG

Thalidomide

Thalidomide 200 mg by mouth daily throughout the cycle.

DRUG

Prednisone

Prednisone 10 mg by mouth daily throughout the cycle.

BIOLOGICAL

bevacizumab

Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.

GENETIC

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.

OTHER

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.

OTHER

laboratory biomarker analysis

Serum and urine samples will be collected at baseline and monthly to measure VEGF (vascular endothelial growth factor) levels.

OTHER

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.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT00089609 - Docetaxel, Thalidomide, Prednisone, and Bevacizumab to Treat Metastatic Prostate Cancer | Biotech Hunter | Biotech Hunter