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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00126230 |
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Date of registration:
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02/08/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Trial of Docetaxel-Samarium in Patients With Hormone-Refractory Advanced Prostate Cancer
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Scientific title:
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A Prospective Phase II Trial of Docetaxel-Samarium in Patients With Hormone-Refractory Advanced Prostate Cancer Who Achieve a Response or a Stabilization to Docetaxel-Estramustine |
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Date of first enrolment:
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January 2004 |
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Target sample size:
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55 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00126230 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Karim Fizazi, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gustave Roussy, Cancer Campus, Grand Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients older than 18 years and less than 80 years
- Histologically-proven adenocarcinoma of the prostate
- Evidence of bone metastases and progressive, hormone-refractory, disease
- No previous chemotherapy
- No previous radiotherapy, except radiotherapy directed to the prostate and/or to a
single bony lesion
- No previous carcinoma, except basal-cell carcinoma of the skin
- Adequate renal function: measured or calculated creatinine clearance > 60 ml/min
- Absolute granulocyte count = 1,500/mm3, platelets = 100,000 mm3, bilirubin = 1.5 fold
the upper normal value
- Signed informed consent.
Exclusion Criteria:
- Patients infected by the Human Immunodeficiency Virus (HIV)
- Patients who do not fit inclusion criteria
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Drug: docetaxel and samarium
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Primary Outcome(s)
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Time to progression
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Secondary Outcome(s)
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Overall survival
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Prostate specific antigen (PSA) response rate
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Toxicity
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Secondary ID(s)
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TAX-SAMAR
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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