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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.


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Neoplasms

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Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A3521002

NCT ID:

NCT00074854

Start Date:

May 2002

Completion Date:

March 2005

Related Keywords:

  • Lung Neoplasms
  • Neoplasms
  • Lung Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteShreveport, Louisiana  71103
Pfizer Investigational SiteBristol, Tennessee  37620