NCT00121095

Study of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Prostate Cancer

Phase I/II Trial of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Androgen-Independent Prostate Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: Cytogen Corporation · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety, tolerability and anti-tumor effects of treatment with samarium Sm-153 lexidronam in combination with docetaxel in patients with castrate metastatic prostate cancer.

Detailed description

The principal objective of this trial is to evaluate the safety, feasibility, and anti-tumor effects of a novel bone-targeted regimen consisting of Samarium Sm-153 lexidronam combined with docetaxel and prednisone. This present study design permits evaluation of the clinical activity of combining two distinct agents that have shown benefit for the treatment of patients with advanced androgen-independent prostate cancer and bone metastases. It enables assessment of potential synergistic interactions between a cytotoxic chemotherapy agent and a bone-targeting radioisotope agent in the setting of a bone-targeted therapy.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	Samarium Sm-153 lexidronam + Docetaxel	1 mCi/kg Sm153 + 75 mg/m2 docetaxel

Timeline

• Start date: 2005-07-01
• Completion: 2008-06-01
• First posted: 2005-07-21
• Last updated: 2007-12-21

Locations

1 site across 1 country: United States