Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Cetuximab; Cisplatin; Vinblastine; Vinorelbine

Criteria

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