This study is designed to address the following questions determining: 1) does escalation of doxorubicin significantly improve patient disease- free and overall survival? If so, how much additional benefit is obtained and at what cost? Is there a plateau in the dose-response curve for doxorubicin? 2) if there is a dose-response to doxorubicin, is this seen in all patients or only in those whose tumors overexpress erbB-2? 3) does the addition of Taxol to a conventional combination of cyclophosphamide and doxorubicin (CA) provide greater benefit than CA alone? Is there an advantage of adding Taxol regardless of the dose of doxorubicin used? This study has a factorial design in which patients will first be randomized to one of three different doses of doxorubicin in the cyclophosphamide/doxorubicin combination (CA) and then rerandomized to receive either four cycles of Taxol or no Taxol.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR005096-09S1
Application #
6298286
Study Section
Project Start
1997-12-01
Project End
1999-06-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
9
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Tulane University
Department
Type
DUNS #
City
New Orleans
State
LA
Country
United States
Zip Code
70118
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