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

Back to results

Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

docetaxel and samarium

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring hormone-refractory advanced prostate cancer who achieve a response or a stabilization to docetaxel-estramustine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Institut Gustave Roussy

Outcomes

Primary Outcome Measures

Time to progression

Secondary Outcome Measures

Prostate specific antigen (PSA) response rate

Toxicity

Overall survival

Full Information

NCT ID

NCT00126230

First Posted

August 2, 2005

Last Updated

September 7, 2006

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

1. Study Identification

Unique Protocol Identification Number

NCT00126230

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Terminated

Study Start Date

January 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

hormone-refractory advanced prostate cancer who achieve a response or a stabilization to docetaxel-estramustine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

55 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

docetaxel and samarium

Primary Outcome Measure Information:

Title

Time to progression

Secondary Outcome Measure Information:

Title

Prostate specific antigen (PSA) response rate

Title

Toxicity

Title

Overall survival

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility 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: Patients infected by the Human Immunodeficiency Virus (HIV) Patients who do not fit inclusion criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karim Fizazi, Dr

Organizational Affiliation

Gustave Roussy, Cancer Campus, Grand Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Gustave Roussy

City

Villejuif

ZIP/Postal Code

94805

Country

France

Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial