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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Docetaxel; Estramustine; Hormones

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