At a glance
ClinicalIndex Comparison Record- ✓Androgen-independent metastatic adenocarcinoma of the prostate with progressive disease while on GnRH agonists or post-surgical castration
- ✓Clinically progressive prostate cancer documented by rising PSA (≥5.0), new bone lesions, or progressive measurable disease
- ✓No prior chemotherapy for metastatic prostate cancer
- ✓Age ≥18 years
- ✕Brain and/or leptomeningeal metastases confirmed by CT or MRI
- ✕Uncontrolled systolic BP ≥170 mmHg or diastolic BP ≥100 mmHg
- ✕Proteinuria with UPC ratio ≥1.0 (or 24-hour urine protein ≥1000 mg if UPC >0.5)
- ✕Therapeutic anticoagulation with coumadin, heparins, or heparinoids
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Docetaxel, Thalidomide, Prednisone and Bevacizumab in Patients With Androgen-Independent Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Docetaxel, Thalidomide, and 6 other interventions for Prostatic Neoplasms. Completed, enrolled 73 participants across 1 site.
Detailed Summary
This is a Phase II study of docetaxel, bevacizumab, prednisone and thalidomide in patients with androgen independent metastatic prostate cancer who are previously untreated with chemotherapy. The primary objective of this study is to determine if the combination of docetaxel, thalidomide and bevacizumab is able to be associated with a sufficiently high proportion of patients with a prostate-specific antigen (PSA) response to be worthy of further investigation in metastatic prostate cancer. We will also be looking at multiple secondary endpoints. These will include possible pharmacokinetic interactions among the study agents, potential correlation between patient genotype and efficacy of treatment. We will also be looking for circulating tumor cells in blood before and after treatment. Additionally we will be monitoring the tolerability of the regimen and survival duration as endpoints as well. We hope to use this trial to build on the promising results seen in our thalidomide/docetaxel protocol where there was a significant PSA decline and a trend toward survival benefit.
Study Details
Timeline
Interventions
Docetaxel 75 mg/m\^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days.
Thalidomide 200 mg by mouth daily throughout the cycle.
Prednisone 10 mg by mouth daily throughout the cycle.
Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
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.
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.
Serum and urine samples will be collected at baseline and monthly to measure VEGF (vascular endothelial growth factor) levels.
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.