This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Non-Small Cell Lung Cancer. - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00047840

Purpose

The purpose of this study is to assess the efficacy and safety of ZD6474 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-Line	Drug: ZD6474 Drug: Placebo Drug: Docetaxel	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Multicenter, Phase II Study to Assess the Safety, Tolerability, and Efficacy of ZD6474 in Combination With Docetaxel (TAXOTERE™) in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of Prior Platinum-Based Chemotherapy.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel Vandetanib

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Outcome Progression free survival

Secondary Outcome Measures:

Incidence and type of adverse events (Aes), clinically significant laboratory abnormalities, and ECG changes;
Objective response rate and duration of response
QoL and lung cancer subscale (LCS) from the FACT-L questionnaire
WHO performance status
Time to death

Estimated Enrollment:	129
Study Start Date:	October 2002
Study Completion Date:	September 2006

Eligibility

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

Criteria

Inclusion Criteria:

Histologic or cytologic confirmation of NSCLC (locally advanced or metastatic, IB-IV)
Failure of first-line platinum-based chemotherapy

Exclusion Criteria:

Mixed small cell or non-small-cell histology
Bronchoalveolar carcinoma
Prior chemotherapy or herbal preparations must be discontinued more than 4 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin and suramin)
Prior treatment with docetaxel

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047840

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Locations

United States, California
Research Site
Los Angeles, California, United States
United States, Florida
Research Site
JACKSONVILLE, Florida, United States
United States, Georgia
Research Site
ATLANTA, Georgia, United States
United States, Louisiana
Research Site
New Orleans, Louisiana, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
Research Site
PITTSFIELD, Massachusetts, United States
United States, Michigan
Research Site
Detroit, Michigan, United States
Research Site
Ann Arbor, Michigan, United States
United States, Montana
Research Site
BILLINGS, Montana, United States
United States, New York
Research Site
New York, New York, United States
Research Site
GREAT NECK, New York, United States
United States, North Carolina
Research Site
Durham, North Carolina, United States
United States, Oregon
Research Site
COOS BAY, Oregon, United States
United States, Pennsylvania
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
United States, Texas
Research Site
Houston, Texas, United States
Czech Republic
Research Site
Brno, Czech Republic
Research Site
Hradec, Czech Republic
Research Site
Plzen, Czech Republic
Research Site
Ostrava, Czech Republic
Research Site
Chomutov, Czech Republic
Research Site
Praha, Czech Republic
Hungary
Research Site
Budapest, Hungary
Research Site
Torokbalint, Hungary
Research Site
Deszk, Hungary
Research Site
Debrecen, Hungary

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

ZD6474 Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	6474IL/0006
Study First Received:	October 18, 2002
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00047840 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Pharmacologic Actions
Carcinoma
Docetaxel
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009