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

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

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

Carboplatin Paclitaxel Tyrosine

U.S. FDA Resources

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.

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

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

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

Study placed in the following topic categories:

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Paclitaxel

Lung Neoplasms

Lung Diseases

Carboplatin

Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on August 21, 2008

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