Clinical trial NCT00050830: A Phase 2, Randomized, Open-Label Study Of Single Agent CI-1033 In Patients With Advanced Non-Small Cell Lung Cancer
Official title: A Phase 2, Randomized, Open-Label Study Of Single Agent CI-1033 In Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-12-24
Enrollment: 163
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 study to determine the activity of CI 1033 against tumors in patients with advanced or metastatic NSCLC who have failed prior platinum-based combination chemotherapy. Another objective is to determine the safety of CI 1033.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically documented diagnosis of progressive or recurrent, locally advanced or metastatic NSCLC; a tumor that expresses at least one member of the erbB family of receptors; failed or relapsed after receiving a platinum-containing regimen as therapy; at least one measurable target lesion as defined by RECIST that has not been irradiated.

Exclusion Criteria:

* Prior exposure to agents that target the erbB receptor family; unknown response to prior platinum-containing chemotherapy regimen; cytotoxic chemotherapy within 3 weeks prior to baseline disease assessments (6 weeks for nitrosoureas or mitomycin); more than 2 prior chemotherapy regimens: immunotherapy or other biologic therapy within 2 weeks prior to baseline disease assessment; prior irradiation to areas encompassing greater than 30% of marrow-bearing bone; brain metastases.

Primary outcomes:
measure: The primary objective is to assess the antitumor activity of CI 1033 in patients with advanced (progressive or recurrent, locally advanced [TNM Stage IIIB] or metastatic [TNM Stage IV]) NSCLC who have failed prior platinum-based combination chemotherapy
Secondary outcomes:
measure: Secondary objectives also include determining the safety of CI 1033 and the detection of any correlations between baseline tumor erbB expression and efficacy. Safety will be assessed by spontaneous AE reporting, physical examinations
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Greenbrae
country: United States
facility: Pfizer Investigational Site
state: California
city: San Fransisco
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: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Park Ridge
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Skokie
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Jefferson
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Crestview Hills
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: LaGrange
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Chippewa Falls
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Eau Claire
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Ladysmith
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Marshfield
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Marshfield
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Minocqua
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Rice Lake
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Stevens Point
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Wausau
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Wisconsin Rapids
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Woodruff
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Gauting
country: Germany
facility: Pfizer Investigational Site
city: Grosshansdorf
country: Germany
facility: Pfizer Investigational Site
city: Heidelberg
country: Germany
facility: Pfizer Investigational Site
city: Cork
country: Ireland
facility: Pfizer Investigational Site
city: Dublin
country: Ireland
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Orbassano (Torino)
country: Italy
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
state: NH
city: Hospitalet de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: