ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.

First Received: October 14, 2003 Last Updated: April 9, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00071188

Purpose

The purpose of the run-in phase of this study is to determine the appropriate and tolerable dose of ZD6474 (200mg or 300mg) to be administered in combination with paclitaxel and carboplatin in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.

The purpose of the randomized phase of this study is to determine the efficacy of ZD6474 alone versus that of ZD6474 in combination with paclitaxel and carboplatin versus that of paclitaxel and carboplatin alone in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: ZD6474 Drug: Paclitaxel Drug: Carboplatin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Partially Blinded, Phase II Study to Assess the Safety, Tolerability and Efficacy of ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Vandetanib

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Study Start Date:	February 2004
Study Completion Date:	October 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed informed consent
18 years or older
Histologically or cytologically confirmed locally advanced or metastatic NSCLC
No prior chemotherapy/biological therapy/radiation therapy
One or more measurable lesions
Life expectancy more than 12 weeks

Exclusion Criteria:

Brain metastases or spinal cord compression
Currently active skin disease
History of significant hemoptysis
Abnormal blood chemistry
Cardiac abnormalities
Recent significant cardiac event
Coexisting malignancies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071188

Hide Study Locations

Locations

United States, California
Research Site
Los Angeles, California, United States
Research Site
Concord, California, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, Missouri
Research Site
St. Louis, Missouri, United States
United States, Rhode Island
Research Site
Providence, Rhode Island, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
United States, Texas
Research Site
Houston, Texas, United States
Research Site
Austin, Texas, United States
Research Site
Lubbock, Texas, United States
United States, Virginia
Research Site
Norfolk, Virginia, United States
United States, Washington
Research Site
Seattle, Washington, United States
Finland
Research Site
Helsinki, Finland
Research Site
Turku, Finland
France
Research Site
Strasbourg, France
Research Site
Besancon, France
Research Site
Lille, France
Germany
Research Site
Essen, Germany
Research Site
Mainz, Germany
Research Site
Ulm, Germany
Research Site
Frankfurt, Germany
India
Research Site
Pune, India
Italy
Research Site
Orbassano, Italy
Research Site
Milano, Italy
South Africa
Research Site
Cape Town, South Africa
Research Site
Johannesburg, South Africa
Research Site
Pretoria, South Africa
Research Site
Parkland, South Africa
Research Site
Panorama, South Africa
Spain
Research Site
Barcelona, Spain
Research Site
Malaga, Spain
Research Site
Madrid, Spain
Research Site
Pamplona, Spain
Thailand
Research Site
Chiang mai, Thailand

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca ZD6474 Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D4200C00007, D4200C00007(run-in), D4200C0007A (randomization)
Study First Received:	October 14, 2003
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00071188 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Non-Small-Cell Lung Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009