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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00074854
First received: December 22, 2003
Last updated: November 8, 2006
Last verified: July 2006
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
  More Information

Additional Information:
No publications provided

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

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

ClinicalTrials.gov processed this record on November 23, 2014