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

This study has been completed.
Sponsor:
Information provided by:
EntreMed
ClinicalTrials.gov Identifier:
NCT00049790
First received: November 13, 2002
Last updated: January 8, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: recombinant human Angiostatin protein
Drug: paclitaxel
Drug: carboplatin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by EntreMed:

Estimated Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049790

Locations
United States, Indiana
Indiana Cancer Pavilion, Indiana University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
EntreMed
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00049790     History of Changes
Other Study ID Numbers: ANG-CL-004
Study First Received: November 13, 2002
Last Updated: January 8, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by EntreMed:
Advanced non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Paclitaxel
Angiostatins
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014