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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00126230
• Other study ID #: TAX-SAMAR
• Status: Terminated
• Phase: Phase 2
• First received: August 2, 2005
• Last updated: September 7, 2006
• Start date: January 2004

Study information

• Verified date: September 2006
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• docetaxel and samarium

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression
Secondary	Prostate specific antigen (PSA) response rate
Secondary	Toxicity
Secondary	Overall survival