NCT00049790

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2002

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

January 9, 2009

Status Verified

January 1, 2009

First QC Date

November 13, 2002

Last Update Submit

January 8, 2009

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Advanced non-small cell lung cancer

Interventions

recombinant human Angiostatin proteinDRUG
paclitaxelDRUG
carboplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana Cancer Pavilion, Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

PaclitaxelCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 13, 2002

First Posted

November 15, 2002

Study Completion

December 1, 2004

Last Updated

January 9, 2009

Record last verified: 2009-01

Locations

US(1)