Clinical trial NCT00112346: Study of Gemcitabine/Platinum +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
Official title: A Randomized Multicenter Phase II Study of Gemcitabine/Platinum/Cetuximab Versus Gemcitabine/Platinum as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small-Cell Lung Carcinoma
Keywords: Non-Small Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-06-02
Enrollment: 120
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 primary purpose of this study is to estimate the number of patients with non-small cell lung cancer whose tumor responds to the treatments given in this study.


Eligibility criteria: Inclusion Criteria:

* Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
* Must not have received cetuximab or any medications that target the same pathway as cetuximab (such as Iressa or Tarceva).
* Must not have had hypersensitivity or severe allergic reactions to any monoclonal antibodies and must not have severe restrictive or interstitial lung disease.
* Must be able to carry out work of light or sedentary nature (e.g. light house work, office work).
* It must be at least 4 weeks since last major surgery or prior treatment with an investigational product and at least 12 weeks from any radiation therapy to the chest.

Exclusion Criteria:

* Women who are pregnant or breastfeeding.
* Women with a positive pregnancy test on enrollment or prior to study drug administration.
* Any concurrent malignancy (subjects with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial).
* Symptomatic or uncontrolled metastases in the central nervous system (CNS).
* Peripheral neuropathy.
* Inadequate hematologic function defined by an absolute neutrophil count (ANC) \<1,500/mm\^3, a platelet count \<100,000/mm\^3, or a hemoglobin level \< 9g/dL.
* Inadequate liver function.
* Inadequate kidney function.

Primary outcomes:
measure: tumor response per treatment arm
Secondary outcomes:
measure: disease control, symptom response, symptomatic progression, & progression free survival.
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Local Institution
state: Alabama
city: Anchorage
country: United States
facility: Local Institution
state: Alaska
city: Bakersfield
country: United States
facility: Local Institution
state: California
city: Corona
country: United States
facility: Local Institution
state: California
city: Oxnard
country: United States
facility: Local Institution
state: California
city: San Diego
country: United States
facility: Local Institution
state: California
city: Whittier
country: United States
facility: Local Institution
state: California
city: Lakewood
country: United States
facility: Local Institution
state: Colorado
city: Boynton Beach
country: United States
facility: Local Institution
state: Florida
city: Brooksville
country: United States
facility: Local Institution
state: Florida
city: Inverness
country: United States
facility: Local Institution
state: Florida
city: Pembroke Pines
country: United States
facility: Local Institution
state: Florida
city: Austell
country: United States
facility: Local Institution
state: Georgia
city: Honolulu
country: United States
facility: Local Institution
state: Hawaii
city: Skokie
country: United States
facility: Local Institution
state: Illinois
city: Muncie
country: United States
facility: Local Institution
state: Indiana
city: Annapolis
country: United States
facility: Local Institution
state: Maryland
city: Frederick
country: United States
facility: Local Institution
state: Maryland
city: Rockville
country: United States
facility: Local Institution
state: Maryland
city: Plymouth
country: United States
facility: Local Institution
state: Massachusetts
city: Farmington
country: United States
facility: Local Institution
state: New Mexico
city: Armonk
country: United States
facility: Local Institution
state: New York
city: Stony Brook
country: United States
facility: Local Institution
state: New York
city: Gastonia
country: United States
facility: Local Institution
state: North Carolina
city: Wilmington
country: United States
facility: Local Institution
state: North Carolina
city: Bismarck
country: United States
facility: Local Institution
state: North Dakota
city: Cincinnati
country: United States
facility: Local Institution
state: Ohio
city: Portland
country: United States
facility: Local Institution
state: Oregon
city: Charleston
country: United States
facility: Local Institution
state: South Carolina
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Vancouver
country: United States
facility: Local Institution
state: Washington
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Moncton
country: Canada
facility: Local Institution
state: New Brunswick
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Windsor
country: Canada
facility: Local Institution
state: Ontario
city: Greenfield Park
country: Canada
facility: Local Institution
state: Quebec
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: