Clinical trial NCT00074854: A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With Chemotherapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lung Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2003-12-24
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
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.
Secondary outcomes:
measure: Given the outcome of the primary objective, analysis of secondary objectives were not formalized.
Other outcomes:
Locations:
city: Greenbrae
country: United States
facility: Pfizer Investigational Site
state: California
city: San Mateo
country: United States
facility: Pfizer Investigational Site
state: California
city: San Pablo
country: United States
facility: Pfizer Investigational Site
state: California
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Covington
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Stony Brook
country: United States
facility: Pfizer Investigational Site
state: New York
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Gallatin
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Hermitage
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Murfreesboro
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Smyrna
country: United States
facility: Pfizer Investigational Site
state: Tennessee
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: