drugset / Trial / NCT00258388

Docetaxel and Prednisone With/Out OGX-011 in Recurrent or Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy

NCT00258388

Phase 2 Completed 82 enrolled NCIC Clinical Trials Group
RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. OGX-011 may help docetaxel and prednisone kill more tumor cells by making tumor cells less resistant to the drugs. PURPOSE: This randomized phase II trial is studying how well giving docetaxel and prednisone with or without OGX-011 works in treating patients with recurrent or metastatic prostate cancer that did not respond to previous hormone therapy.

Timeline

Start
2005-09-28
Primary completion
2007-11-08
Completion
2011-01-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator custirsen Antisense oligonucleotide 640 mg Intravenous
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Comparator Prednisone Other / unclassified 5 mg Oral

Indications