The purpose of this study is to determine the safety and efficacy of rhAngiostatin protein administered in combination with paclitaxel and carboplatin to patients with non-small-cell lung cancer.
Histological or cytological confirmed Stage IIIB NSCLC with malignant pleural effusions, or Stage IV NSCLC or recurrent NSCLC No previous chemotherapy for NSCLC Have one lesion that is bidimensionally measurable by physical exam, MRI, or CT greater than 1 cm in diameter Specified lab parameters Life expectancy of at least 12 weeks ECOG performance status of 0 or 1 Understand requirements of study Agree to use effective contraceptive methods
Exclusion:
Have CNS metastases Have any active cancer in addition ot NSCLC Participated in clinical trial involving conventional or investigational drugs within previous 4 weeks Have any contraindication to paclitaxel or carboplatin Have had Grade 3 or greater peripheral neuropathies Be pregnant or lactating Have a history of myocardial infarction or angina pectoris/angina in the last 6 months Have had significant (30 mL or more) hemoptysis with the past 3 months Have an active infection Have a history of bleeding diathesis, hypercoagulable condition, or an active bleeding disorder Be receiving concurrent treatment with therapeutic doses of heparin or coumadin Have had major surgery within 4 weeks of stating therapy Have additional uncontrolled serious medical conditions or psychiatric illness Received rhAngiostatin in other clinical protocols
