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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:
ClinicalTrials.gov Identifier:
NCT00049790
First Posted: November 15, 2002
Last Update Posted: January 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
CASI Pharmaceuticals, Inc.
  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 CASI Pharmaceuticals, Inc.:

Estimated Study Completion Date: December 2004
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049790


Locations
United States, Indiana
Indiana Cancer Pavilion, Indiana University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
CASI Pharmaceuticals, Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00049790     History of Changes
Other Study ID Numbers: ANG-CL-004
First Submitted: November 13, 2002
First Posted: November 15, 2002
Last Update Posted: January 9, 2009
Last Verified: January 2009

Keywords provided by CASI Pharmaceuticals, Inc.:
Advanced non-small cell lung cancer

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


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