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

Status:	Completed
Conditions:	Lung Cancer, Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	July 2010
End Date:	September 2012

Cisplatin and Vinorelbine in Combination With Cetuximab as First Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC): a Single Arm Multicenter Safety Phase 2 Study

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.

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

We found this trial at

sites

Elite Research Institute

15705 NW 13th
Miami, Florida 33169

305-620-7002