Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer
Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
Participant gender:
Summary
The anticancer agent paclitaxel (Taxol for Injection Concentrate, Bristol-Meyers Squibb) has
a broad spectrum of activity against several human cancers including carcinomas of ovary,
breast, lung, esophagus and head and neck cancer. Taxol has shown remarkable activity against
metastatic breast cancer, yielding response rates in the range of 40% to 60% in
chemotherapy-naive patients and 25%-30% in patients refractory to anthracycline-containing
regimens (Taxol package insert). The major limitation of Taxol is its poor water soluability
requiring Cremophor (containing castor oil and ethanol) as a solvent. Taxol in this vehicle
must be administered over 3-24 hours, and hypersensitivity reactions to Cremophor require a
premedication routine of a corticosteroid, an antihistamine, and an H2 antagonist.