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A Phase III Trial of ZD4054 (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer - NCT00617669-(Clinical Trial 203172)



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City:  Milwaukee
State:  
WI
Zip Code:
Conditions: Prostate Cancer
Purpose: Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC). This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 can further improve survival compared with docetaxel alone. ZD4054 is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 in hormone resistant prostate cancer patients with bone metastases compared with docetaxel. All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies. Half the patients will receive ZD4054, and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further slow the progression of the tumour. No patients will be deprived of standard prostate cancer therapy.
Study summary:
Criteria: Inclusion Criteria: Patients who answer TRUE to the following criteria may be eligible to participate in this trial. - Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastasis) - Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment - Currently receiving treatment with surgical or medical castration Exclusion Criteria: Patients who answer TRUE to the following ARE NOT eligible to participate in this trial. - Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial. - Suffering from heart failure or had a myocardial infarction within last 6 months - A history of epilepsy or seizures
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: May 11, 2010
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