Samarium 153 Lexidronam |
Quadramet |
Clinical Trial: Trial of Docetaxel-Samarium in Patients with Hormone-Refractory Advanced Prostate Cancer
This study is currently recruiting patients.
Verified by Institut Gustave Roussy August 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Prostate Cancer | Drug: docetaxel and samarium | Phase II |
MedlinePlus related topics: Prostate Cancer
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: 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
Secondary Outcomes: Prostate specific antigen (PSA) response rate; Toxicity; Overall survival
Expected Total Enrollment: 55
Study start: January 2004
Eligibility
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
Location and Contact Information
France
Institut Gustave Roussy, Villejuif, 94805, France; Recruiting
Karim Fizazi, Dr, Principal Investigator, Institut Gustave Roussy
More Information
Last Updated: August 16, 2005
Record first received: August 2, 2005
ClinicalTrials.gov Identifier: NCT00126230
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-08-23

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