A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With Chemotherapy - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00074854

Purpose

The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase inhibitor when given in combination with chemotherapy (carboplatin and paclitaxel) is effective in the treatment of advanced stage non-small cell lung cancer.

Condition	Intervention	Phase
Lung Neoplasms	Drug: CP-547,632	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With Chemotherapy (Paclitaxel And Carboplatin) Vs. Chemotherapy Alone For The Treatment Of Advanced Stage Non-Small Cell Lung Cancer.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Tyrosine

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Statistical estimates used on the Stage 1 data indicated low likely-hood of a positive outcome if the study continued to Stage 2. This provided the basis for discontinuation of the trial.

Secondary Outcome Measures:

Given the outcome of the primary objective, analysis of secondary objectives were not formalized.

Estimated Enrollment:	87
Study Start Date:	May 2002
Estimated Study Completion Date:	March 2005

Eligibility

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

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed stage IIIB (inicluding those with pleural effusion), IV or recurrent non-small cell lung cancer (nsclc).
Bidimensionally measurable disease >2cm x 1 cm by conventional CT Scan or >1 cm x 1cm by spiral CT Scan.

Exclusion Criteria:

No tumors in close proximity to major veins or arteries.
No sanguinous pleural effusion due to disease or pericardial effusion suspicious for disease.
No evidence or history brain metastases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074854

Locations

United States, California
Pfizer Investigational Site
Greenbrae, California, United States, 94904
Pfizer Investigational Site
GREENBRAE, California, United States, 94904
Pfizer Investigational Site
San Mateo, California, United States, 94402
Pfizer Investigational Site
San Pablo, California, United States, 94806
United States, Florida
Pfizer Investigational Site
TAMPA, Florida, United States, 33612-9497
United States, Louisiana
Pfizer Investigational Site
Covington, Louisiana, United States, 70433
Pfizer Investigational Site
Metairie, Louisiana, United States, 70002
Pfizer Investigational Site
Metairie, Louisiana, United States, 70006
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70115
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
United States, New York
Pfizer Investigational Site
Stony Brook, New York, United States, 11794
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Pfizer Investigational Site
Gallatin, Tennessee, United States, 37066
Pfizer Investigational Site
Hermitage, Tennessee, United States, 37076
Pfizer Investigational Site
Lebanon, Tennessee, United States, 37087
Pfizer Investigational Site
Murfreesboro, Tennessee, United States, 37130
Pfizer Investigational Site
Smyrna, Tennessee, United States, 37167
Pfizer Investigational Site
Nashville, Tennessee, United States, 37205
Pfizer Investigational Site
Nashville, Tennessee, United States, 37207
Pfizer Investigational Site
NASHVILLE, Tennessee, United States, 37211
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A3521002
Study First Received:	December 22, 2003
Last Updated:	November 8, 2006
ClinicalTrials.gov Identifier:	NCT00074854 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases

Tyrosine
Non-small Cell Lung Cancer
Carboplatin
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on September 04, 2009