Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer
NCT ID: NCT01109524
Last Updated: 2015-12-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2010-07-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cetuximab + Cisplatin + Vinorelbine
Cetuximab
Vial, Intravenous, 400mg/m², week 1, then 250mg/m², Weekly, Until Progressive Disease (PD)/ Toxicity/Pt-PI Decision
Cisplatin
Vial, Intravenous, 80mg/m², Day 1 of each 21 day cycle, Maximum 6 cycles
Vinorelbine
Vial, Intravenous, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles
Interventions
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Cetuximab
Vial, Intravenous, 400mg/m², week 1, then 250mg/m², Weekly, Until Progressive Disease (PD)/ Toxicity/Pt-PI Decision
Cisplatin
Vial, Intravenous, 80mg/m², Day 1 of each 21 day cycle, Maximum 6 cycles
Vinorelbine
Vial, Intravenous, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Evaluable or measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Exclusion Criteria
* Previous exposure to monoclonal antibodies, signal transduction inhibitors or Epidermal growth factor receptor (EGFR) targeting therapy
* Concurrent malignancy
* Prior chemotherapy for NSCLC
* Pre-existing ascites grade ≥ 2 or pericardial effusion grade ≥ 2
* Superior vena cava syndrome contra-indicating hydration
* White Blood Cells (WBC) \< 3,000/mm³
* Absolute neutrophile count (ANC) \< 1,500/mm³
* Platelet \< 100,000/mm³
* Hemoglobin (Hgb) \< 9.0 g/dL
* Total bilirubin \> 1.5 x Upper limit of normal (ULN).
* Aspartate aminotransferase (AST) or Alanine-aminotransferase (ALT) \> 5.0 x ULN.
* Serum creatinine \>1.25 x ULN and calculated creatinine clearance \<60mL/min
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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Donald W. Hill M.D., P.C.
Casa Grande, Arizona, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
Cancer Care Institute
Los Angeles, California, United States
Northern California Hematology & Oncology
Oakland, California, United States
Sharp Clinical Oncology Research
San Diego, California, United States
Broward Oncology Associates, P.A.
Fort Lauderdale, Florida, United States
Elite Research Institute
Miami, Florida, United States
Edward H. Kaplan, MD & Associates
Skokie, Illinois, United States
Fairview Southdale Medical Oncology Clinic
Edina, Minnesota, United States
Mid Dakota Clinic, Pc
Bismarck, North Dakota, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University Medical Center
Lubbock, Texas, United States
Columbia Basin Hematology and Oncology
Kennewick, Washington, United States
The Moncton Hospital
Moncton, New Brunswick, Canada
Local Institution
Grand Falls-Windsor, Newfoundland and Labrador, Canada
Sudbury Regional Hospital
Greater Sudbury, Ontario, Canada
The Credit Valley Hospital
Mississauga, Ontario, Canada
Thunder Bay Regional Health Sciences Centre (Regional Cancer Care)
Thunder Bay, Ontario, Canada
Toronto East General Hospital
Toronto, Ontario, Canada
Centre de sante et de services sociaux de Rimouski-Neigette
Rimouski, Quebec, Canada
Ponce School of Medicine (Caimed Center)
Ponce, , Puerto Rico
Fundacion de Investigacion de Diego
San Juan, , Puerto Rico
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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CA225-346
Identifier Type: -
Identifier Source: org_study_id