Discovered in the 1960s, Taxol had originally shown activity against several murine leukemias and solid tumors. Significant clinical antitumor activity was first demonstrated in advanced ovarian cancer. Taxol also has shown to have antitumor activity in patients with metastatic breast cancer who received no prior chemotherapy or one prior chemotherapy regime. Used mostly in a 24-hour infusion in the past, as more information concerning the efficacy and safety of taxol is accumulated, there has been increased justification for the evaluation of Taxol in the adjuvant setting. It has been determined that the maximum dosage of Taxol given in a 3-hour infusion without the support of G-CSF is 210mg/m2. G-CSF will be added in subsequent cycles in the event of hematologic toxicity, septic episode, or serious infection following taxol administration. This study will dose compare the effect of a 3- hour versus 24-hour infusion of high dose Taxol in women with metastatic (stage IV) or locally advanced stage IIB breast cancer.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR005096-09S1
Application #
6298282
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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