Non-Small Cell Lung Cancer Clinical Trial
Official title:
An Open-label, Phase I/II Trial of ABI-007 (A Cremophor EL-Free, Protein Stabilized, Nanoparticle, Paclitaxel) Administered Weekly in Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer
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.
ABI-007, a unique protein formulation of paclitaxel, has been developed to reduce the
toxicities associated with Taxol and Cremophor EL/ethanol vehicle while maintaining or
improving the chemotherapeutic effect of the drug.
The activity of ABI-007 in other malignancies is not yet well established. This open-label
Phase I/II study is being conducted to define the maximum tolerated dose (MTD) and
dose-limiting toxicities (DLT) of ABI-007, and evaluate the safety and antitumor activity of
ABI-007 in patients with advanced Stage IV non-small cell lung cancer (NSCLC).
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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