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A Phase I/II Study of Azacitidine, Docetaxel, and Prednisone for Metastatic Prostate Cancer Patients

NCT00503984 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2016-06-09

Study results available
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Summary

Azacitidine can reverse clinical resistance to docetaxel through upregulation of Growth Arrest and DNA Damage inducible alpha (GADD45α) and other epigenetically regulated genes.

Conditions

Interventions

DRUG

Azacitidine

Intravenous infusion over 30 minutes Days 1 - 5 of each 3 weekly cycle.

DRUG

Docetaxel

Intravenous infusion over 1 hour on day 6 of each 3 weekly cycle.

DRUG

Prednisone

Patient will receive prednisone 5mg twice a day from Day 1 to 21 of each cycle.

GENETIC

GADD45α methylation and expression analysis

Peripheral blood samples from patients will be collected as described in section 8.1 (total of 4 blood samples). DNA will be isolated from serum, bisulfite treated and evaluated for methylation by bisulfite genomic sequencing. Patients with accessible prostate tissue or metastases will undergo biopsy prior to treatment if they consent to do so.

DRUG

Pegfilgrastim

Growth factor support.Granulocyte-colony stimulating factor (G-CSF)

DRUG

Filgrastim

Growth factor support. Granulocyte-colony stimulating factor (G-CSF)

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Rakesh Singal, MD · University of Miami Sylvester Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00503984 on ClinicalTrials.gov