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.

Condition	Treatment or Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: recombinant human Angiostatin protein  Drug: paclitaxel  Drug: carboplatin	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Indiana
      Indiana Cancer Pavilion, Indiana University, Indianapolis,  Indiana,  46202,  United States; Recruiting

Study ID Numbers:  ANG-CL-004
Record last reviewed:  November 2002
Record first received:  November 13, 2002
ClinicalTrials.gov Identifier:  NCT00049790
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10