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

September 7, 2006 updated by: Gustave Roussy, Cancer Campus, Grand Paris

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Villejuif, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to progression

Secondary Outcome Measures

Outcome Measure
Toxicity
Overall survival
Prostate specific antigen (PSA) response rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Investigators

  • Principal Investigator: Karim FIZAZI, Dr, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Registration Dates

First Submitted

August 2, 2005

First Submitted That Met QC Criteria

August 2, 2005

First Posted (Estimate)

August 3, 2005

Study Record Updates

Last Update Posted (Estimate)

September 11, 2006

Last Update Submitted That Met QC Criteria

September 7, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAX-SAMAR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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