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