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

Gustave Roussy

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: docetaxel and samarium

Study type: Interventional

Funder types: Other

Identifiers

NCT00126230

TAX-SAMAR

Details and patient eligibility

About

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.

Sex: Male

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)