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

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ClinicalTrials.gov Identifier: NCT00074854
Recruitment Status : Completed
First Posted : December 24, 2003
Last Update Posted : November 9, 2006
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Lung Neoplasms Drug: CP-547,632 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : May 2002
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. Given the outcome of the primary objective, analysis of secondary objectives were not formalized.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): NCT00074854


Locations
United States, California
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
Nashville, Tennessee, United States, 37203
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
Smyrna, Tennessee, United States, 37167
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
ClinicalTrials.gov Identifier: NCT00074854     History of Changes
Other Study ID Numbers: A3521002
First Posted: December 24, 2003    Key Record Dates
Last Update Posted: November 9, 2006
Last Verified: July 2006

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases