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

This study has been terminated.
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00126230
First received: August 2, 2005
Last updated: September 7, 2006
Last verified: September 2006
  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 2

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

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Time to progression

Secondary Outcome Measures:
  • Prostate specific antigen (PSA) response rate
  • Toxicity
  • Overall survival

Estimated Enrollment: 55
Study Start Date: January 2004
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126230

Locations
France
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Karim Fizazi, Dr Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00126230     History of Changes
Other Study ID Numbers: TAX-SAMAR
Study First Received: August 2, 2005
Last Updated: September 7, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
hormone-refractory advanced prostate cancer who achieve a response or a stabilization to docetaxel-estramustine

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Docetaxel
Hormones
Antimitotic Agents
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 30, 2014