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Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer

Lung Cancer Clinical Trial

Official title:
Phase II Study of C225 (Cetuximab) for the Treatment of Patients With Advanced Bronchioalveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features

Clinical Trial Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with recurrent or stage IIIB or stage IV lung cancer.

Clinical Trial Description

OBJECTIVES: Primary - Determine the objective response rate in patients with recurrent or stage IIIB or IV bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features treated with cetuximab. Secondary - Determine the overall survival and time to progression in patients treated with this drug. - Determine the toxic effects of this drug in these patients. - Correlate expression of total and phosphorylated epidermal growth factor receptor (EGFR), total and phosphorylated AKT3, and total and phosphorylated MAPKinase with response in patients treated with this drug. - Determine whether the presence of polymorphisms or mutations in the EGFR gene influences response in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1-2 hours once on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years. ACTUAL ACCRUAL: A total of 72 patients were accrued for this study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00103207
Study type Interventional
Source Eastern Cooperative Oncology Group
Contact
Status Completed
Phase Phase 2
Start date October 13, 2005
Completion date August 2012
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