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

January 8, 2009 updated by: CASI pharmaceuticals, Inc.

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.

Study Overview

Status

Completed

Conditions

Carcinoma, Non-Small-Cell Lung

Intervention / Treatment

Study Type

Interventional

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Indiana Cancer Pavilion, Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CASI pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

November 13, 2002

First Submitted That Met QC Criteria

November 14, 2002

First Posted (Estimate)

November 15, 2002

Study Record Updates

Last Update Posted (Estimate)

January 9, 2009

Last Update Submitted That Met QC Criteria

January 8, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Advanced non-small cell lung cancer

Additional Relevant MeSH Terms

Other Study ID Numbers

ANG-CL-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.