NCT00126230

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2005

Completed
Last Updated

September 11, 2006

Status Verified

September 1, 2006

First QC Date

August 2, 2005

Last Update Submit

September 7, 2006

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Time to progression

Secondary Outcomes (3)

  • Prostate specific antigen (PSA) response rate

  • Toxicity

  • Overall survival

Interventions

docetaxel and samariumDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients infected by the Human Immunodeficiency Virus (HIV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

DocetaxelSamarium

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesLanthanoid Series ElementsMetals, Rare EarthElementsInorganic ChemicalsMetals

Study Officials

  • Karim Fizazi, Dr

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2005

First Posted

August 3, 2005

Study Start

January 1, 2004

Last Updated

September 11, 2006

Record last verified: 2006-09

Locations

FR(1)