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
18 Years
N/A
Not Enrolling
Both
Lung Neoplasms
Both
Lung Neoplasms
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 Site | Blendora, California 91740 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | North Adams, Massachusetts 01247 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
| Pfizer Investigational Site | Shreveport, Louisiana 71103 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
