Status:
TERMINATED
Trial of Docetaxel-Samarium in Patients With Hormone-Refractory Advanced Prostate Cancer
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
PHASE2
Brief Summary
This is 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.
Eligibility Criteria
Inclusion
- 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
- Patients infected by the Human Immunodeficiency Virus (HIV)
- Patients who do not fit inclusion criteria
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00126230
Start Date
January 1 2004
Last Update
September 11 2006
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, 94805