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NCT00074854 Clinical Trial

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

Lung Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00074854
Other study ID # A3521002
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received December 22, 2003
Last updated November 8, 2006
Start date May 2002
Est. completion date March 2005

Study information
Verified date July 2006
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 87
Est. completion date March 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• CP-547,632

Locations
Country Name City State
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Covington Louisiana
United States Pfizer Investigational Site Gallatin Tennessee
United States Pfizer Investigational Site Greenbrae California
United States Pfizer Investigational Site Hermitage Tennessee
United States Pfizer Investigational Site Lebanon Tennessee
United States Pfizer Investigational Site Metairie Louisiana
United States Pfizer Investigational Site Metairie Louisiana
United States Pfizer Investigational Site Murfreesboro Tennessee
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site San Mateo California
United States Pfizer Investigational Site San Pablo California
United States Pfizer Investigational Site Smyrna Tennessee
United States Pfizer Investigational Site Stony Brook New York
United States Pfizer Investigational Site Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Given the outcome of the primary objective, analysis of secondary objectives were not formalized.
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