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

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Indiana Cancer Pavilion, Indiana University

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recombinant human Angiostatin protein

Drug

paclitaxel

Drug

carboplatin

Drug

Sponsors and collaborators

Lead sponsor

CASI pharmaceuticals, Inc.

Industry

Registry information

Important dates

Study completion: 2004
First posted: Nov 15, 2002
Registry last updated: Jan 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed