Trial of Docetaxel-Samarium in Patients With Hormone-Refractory Advanced Prostate Cancer
Phase 2
Terminated
- Conditions
- Prostate Cancer
- Registration Number
- NCT00126230
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 55
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Time to progression
- Secondary Outcome Measures
Name Time Method Prostate specific antigen (PSA) response rate Toxicity Overall survival
Trial Locations
- Locations (1)
Institut Gustave Roussy
🇫🇷Villejuif, France