drugset / Trial / NCT00063934

Oblimersen Plus Doxorubicin and Docetaxel in Treating Patients With Metastatic or Locally Advanced Breast Cancer

NCT00063934

Phase 1/2 Terminated 31 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This phase I/II trial is studying the side effects and best dose of oblimersen when given together with doxorubicin and docetaxel and to see how well they work in treating women with metastatic or locally advanced breast cancer. Drugs used in chemotherapy, such as doxorubicin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of doxorubicin and docetaxel by making the tumor cells more sensitive to the drugs.

Timeline

Start
2003-05
Primary completion
2008-02
Completion
2008-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule Intravenous
Subject Doxorubicin Other / unclassified Intravenous
Subject oblimersen sodium Antisense oligonucleotide Intravenous
Background Pegfilgrastim Protein / enzyme biologic Subcutaneous
Background filgrastim Protein / enzyme biologic Subcutaneous

Indications