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A Phase I/II Study of Azacitidine, Docetaxel, and Prednisone for Metastatic Prostate Cancer Patients | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

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

A Phase I/II Study of Azacitidine (Vidaza), Docetaxel and Prednisone for Patients With Hormone Refractory Metastatic Prostate Cancer Previously Treated With a Taxotere Containing Regimen.

NCT00503984•University of Miami

View on ClinicalTrials.gov

Summary

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

Detailed Description

Study design A phase I/II clinical trial in patients with hormone refractory metastatic prostate cancer. Primary objective phase I component of study: To determine a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer. Primary objective phase II component of study: To determine the therapeutic efficacy of combined therapy of azacitidine, docetaxel, and prednisone, in the treatment of hormone refractory metastatic prostate cancer. The primary measure of therapeutic efficacy is response, defined as prostate-specific antigen (PSA) response, complete response (CR), or partial response (PR). Secondary endpoints are toxicity, duration of response, progression-free survival, and overall survival.

Eligibility

Age

18 - 120 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Patient who had histologically confirmed adenocarcinoma of the prostate.
•Patient must have radiologically documented metastatic disease.
•Patients should have received at least 12 weeks of docetaxel chemotherapy or a cumulative docetaxel dose of 300 mg/m2 and have disease progression on docetaxel-based therapy. Patients must have progressed after prior hormonal therapy (e.g. medical or surgical castration) as defined by a castrate level of testosterone (less than 50 ng/mL). If patient underwent medical castration, it must be continued during the study.
•Progressive disease may be documented by:
•* Non-measurable disease:
•* Serum PSA progression defined as a rise in at least 2 consecutive serum PSA values, each obtained at least 1 week apart and an absolute value greater than 2.0 ng/ml or,
•* Appearance of two or more new lesions on bone scan.
•* Patients with treated epidural lesions and no other epidural progression will be eligible.
•* Measurable disease
•* Documented progression of disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria demonstrating at least one visceral or soft tissue metastatic lesion (including new lesion).
+17 more criteria

Exclusion Criteria

•Patients who have received strontium 89 (metastron®), Samarium 153 (quadramet®) radiation therapy within 8 weeks of enrollment.
•Evidence of significant active infection during screening for eligibility.
•Patients who have had a psychiatric illness that could potentially interfere with completion of treatment according to protocol.
•Patients who had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. There is no wash-out period for patients who received Zytiga.
•Patient who had brain metastases.
•Patient who had history of allergic reactions attributed to compound or similar chemical or biological composition to azacitidine (Vidaza®) or docetaxel or other drugs formulated with polysorbate 80 or mannitol.
•Patient had major surgical procedure within 28 days before Day 1 of treatment.
•Hepatic malignancy.

Locations (1)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Key Dates

Start Date

May 1, 2007

Primary Completion Date

June 1, 2015

Completion Date

June 1, 2015

Last Updated

June 9, 2016

Enrollment

ACTUAL participants

Conditions

Prostate CancerPain

Interventions

Azacitidine

DRUG

Docetaxel

DRUG

Prednisone

DRUG

GADD45α methylation and expression analysis

GENETIC

Pegfilgrastim

DRUG

Filgrastim

DRUG

Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.

NCT06346132

Virtual RealityMedical Device+2 more

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 9, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)