Study of ABI-007 and Taxol in Patients With Metastatic Breast Cancer
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Paclitaxel (Taxol, Bristol-Meyers Squibb) has been shown to be very effective against
metastatic breast cancer, as well as other cancers. Because the Taxol formulation of
paclitaxel is dissolved in Cremophor, an organic solvent containing castor oil, and ethanol,
prolonged intravenous administration times are required; and because the solvent has caused
hypersensitivity reactions, a premedication schedule is required. ABI-007 is a new anticancer
medication containing the same active ingredient as Taxol, paclitaxel, but formulated as a
protein-stabilized material that is suspended in salt water and administered intravenously.
The time of administration is reduced, the dose of paclitaxel can be higher than is safe for
Taxol, and there is no premedication required.
This study will determine the efficacy of this new formulation of paclitaxel, as compared to
Taxol, for patients with metastatic breast cancer.
This is an open label comparative study, so patients will be randomly assigned to receive
either the Taxol or ABI-007 forms of paclitaxel, but will know what medication they are
receiving. Treatment will be repeated every three weeks unless adverse events or treatment
failure require discontinuing study medication.