Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer

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).

Patients must be:

• Histologically or cytologically confirmed advanced stage IV NSCLC with evidence of inoperable local recurrence or metastasis
• If female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
• Eighteen years of age or older
• No other current active malignancy
• Measurable disease (defined by RECIST criteria) documented radiographically
• Patient must have received no prior chemotherapies for the treatment of metastatic disease. Radiation therapy to a major bone marrow-containing area must have been completed 3 or more weeks prior to study entry. Prior treatment with EGF-targeted therapies is permitted.
• If, at baseline, patient has ANC greater than or equal to 1.5 x 109 cells/L; platelets greater than or equal to 100 x 109 cells/L and Hgb greater than or equal to 9 g/dL
• If, at baseline, patient has AST and ALT of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin NORMAL; creatinine levels less than or equal to 1.5 mg/dL and alkaline phosphatase levels less than or equal to 2.5 x the upper limit of normal range (unless alkaline phosphatase elevation is felt to be related to bone metastases and there is no radiologic evidence of hepatic metastasis)
• Expected survival of greater than 12 weeks
• ECOG performance status 0-1 (Karnofsky > 70)
• Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.