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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00049790
Enrollment
Unknown
Registered
2002-11-15
Start date
Unknown
Completion date
2004-12-31
Last updated
2009-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Advanced non-small cell lung cancer

Brief 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.

Interventions

DRUGrecombinant human Angiostatin protein
DRUGpaclitaxel
DRUGcarboplatin

Sponsors

CASI Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026