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Trial of Docetaxel-Samarium in Patients with Hormone-Refractory Advanced Prostate Cancer - Article


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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

Sponsored by: Institut Gustave Roussy
Information provided by: Institut Gustave Roussy
ClinicalTrials.gov Identifier: NCT00126230

Purpose

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.
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

Further Study Details: 
Primary Outcomes: Time to progression
Secondary Outcomes: Prostate specific antigen (PSA) response rate; Toxicity; Overall survival
Expected Total Enrollment:  55

Study start: January 2004

Eligibility

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Male
Criteria

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:

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00126230

Karim Fizazi, Dr      33 1 42114559    fizazi@igr.fr

France
      Institut Gustave Roussy, Villejuif,  94805,  France; Recruiting
Karim Fizazi, Dr  33 1 42114559    fizazi@igr.fr 

Study chairs or principal investigators

Karim Fizazi, Dr,  Principal Investigator,  Institut Gustave Roussy   

More Information

Study ID Numbers:  TAX-SAMAR
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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Page Updated: June 1, 2005
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