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

Inclusion Criteria

• •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
• +2 more criteria