Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer
The purpose of the study is to determine if U.S. manufactured Cetuximab can be safely used for the treatment of Non-Small Cell Lung Cancer in combination with Cisplatin and Vinorelbine.
Checked against the public recordLast updated Dec 24, 2015 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Eli Lilly and Company
- Interventions being studied
- Drug: Cetuximab; Drug: Cisplatin; Drug: Vinorelbine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Non-Small Cell Lung Cancer (NSCLC), Stage IV (per the American Joint Committee on Cancer (AJCC) Staging Manual, Seventh Edition) or recurrent disease following surgery and/or radiation therapy * Evaluable or measurable disease * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 Exclusion Criteria: * Uncontrolled Central Nervous System (CNS) metastasis. * 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Donald W. Hill M.D., P.C.Casa Grande, Arizona
- Beverly Hills Cancer CenterBeverly Hills, California
- Cancer Care InstituteLos Angeles, California
- Northern California Hematology & OncologyOakland, California
- Sharp Clinical Oncology ResearchSan Diego, California
- Broward Oncology Associates, P.A.Fort Lauderdale, Florida
- Elite Research InstituteMiami, Florida
- Edward H. Kaplan, MD & AssociatesSkokie, Illinois
- Fairview Southdale Medical Oncology ClinicEdina, Minnesota
- Mid Dakota Clinic, PcBismarck, North Dakota
- Temple University HospitalPhiladelphia, Pennsylvania
- University Medical CenterLubbock, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 24, 2015. Always confirm current availability with the study team.