Status:
COMPLETED
Study of Taxane/Carboplatin +/- 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:
PHASE3
Brief Summary
The primary purpose of this clinical research study is to learn if patients treated with the combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free survival than patie...
Eligibility Criteria
Inclusion
- Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
- Tumor/disease lesions that can be measured bidimensionally.
- Must be able to carry-out work of light or sedentary nature (e.g. light house work, office work).
- Adequate recovery from recent surgery or radiation therapy.
- Must be at least 4 weeks from last major surgery or prior treatment with an investigational agent. At least 12 weeks from any radiation therapy to chest.
- Accessible for treatment, follow-up and required visits at a participating center(s).
Exclusion
- Prior chemotherapy or adjuvant chemotherapy for the treatment of lung cancer.
- Prior treatment with cetuximab or other epidermal growth factor (EGFR)-targeted therapy.
- Prior severe infusion reaction to antibody therapy.
- Concurrent malignancy (previous malignancy without evidence of disease for 5 years will be allowed to enter trial).
- Concurrent chemotherapy or therapy with another investigational agent not indicated in the protocol.
- Serious uncontrolled medical disorders that would impair the ability to receive therapy.
- History of myocardial infarction within prior 3 months, uncontrolled angina, uncontrolled arrhythmia, or uncontrolled congestive heart failure.
- Symptomatic or uncontrolled metastases in the central nervous system. Subjects receiving a glucocorticoid for central nervous system (CNS) metastases are not eligible, but those receiving an anticonvulsant are eligible.
- Peripheral neuropathy \>= grade 2 (Common Toxicity Criteria Adverse Event \[CTCAE\] Version 3.0).
- Inadequate hematologic and/or liver and/or kidney function.
- Sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for entire trial and up to 4 weeks after the study.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment prior to study drug administration.
- Altered mental status or psychiatric condition that prohibits understanding or rendering of consent.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
755 Patients enrolled
Trial Details
Trial ID
NCT00112294
Start Date
December 1 2004
End Date
August 1 2008
Last Update
December 24 2015
Active Locations (124)
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1
Local Institution
Birmingham, Alabama, United States
2
Local Institution
Mobile, Alabama, United States
3
Local Institution
Anchorage, Alaska, United States
4
Local Institution
Tucson, Arizona, United States