Safety and Efficacy Study of rhAngiostatin Administered in Combination With Paclitaxel and Carboplatin to Patients With Non-Small-Cell Lung Cancer

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CASI Pharmaceuticals, Inc.
• Treatments: Albumin-Bound Paclitaxel; Angiostatins; Carboplatin; Paclitaxel

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