Status:
COMPLETED
Study of Gemcitabine/Platinum +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Non-Small-Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00112346
Start Date
January 1 2005
End Date
December 1 2006
Last Update
October 28 2015
Active Locations (38)
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1
Local Institution
Mobile, Alabama, United States
2
Local Institution
Anchorage, Alaska, United States
3
Local Institution
Bakersfield, California, United States
4
Local Institution
Corona, California, United States