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

NCT ID: NCT00049790

Last Updated: 2009-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Completion Date

2004-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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recombinant human Angiostatin protein

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

carboplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CASI Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Locations

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Indiana Cancer Pavilion, Indiana University

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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ANG-CL-004

Identifier Type: -

Identifier Source: org_study_id

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