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

CASI Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: carboplatin; Drug: paclitaxel; Drug: recombinant human Angiostatin protein

Study type: Interventional

Funder types: Industry

Identifiers

NCT00049790

ANG-CL-004

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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