Lung Cancer Clinical Trial
Safety and Efficacy Study of rhAngiostatin Administered in Combination With Paclitaxel and Carboplatin to Patients With Non-Small-Cell Lung Cancer
Summary
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.
Eligibility Criteria
Inclusion:
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
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There is 1 Location for this study
Indianapolis Indiana, 46202, United States
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