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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


Phase 2
18 Years
80 Years
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to progression

Principal Investigator

Karim Fizazi, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

TAX-SAMAR

NCT ID:

NCT00126230

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Prostate Cancer
  • hormone-refractory advanced prostate cancer who achieve a response or a stabilization to docetaxel-estramustine
  • Prostatic Neoplasms

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