Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase I Clinical and Biological Evaluation of Combined EGFR Blockade With Erlotinib and Cetuximab in Patients With Advanced Cancer
This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with cetuximab and to see how well they work in treating patients with advanced gastrointestinal cancer, head and neck cancer, non-small cell lung cancer, or colorectal cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Erlotinib hydrochloride and cetuximab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with cetuximab may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To identify the maximum tolerated dose (MTD). II. To identify the recommended dose (RD)
for phase II of erlotinib (erlotinib hydrochloride) in combination with cetuximab in
patients (pts) with incurable gastrointestinal, head and neck, or non-small cell lung
cancers that are Kirsten rat sarcoma viral oncogene homolog (KRAS) wild type.
SECONDARY OBJECTIVES:
I. To identify dose-limiting toxicities (DLT). II. To perform skin and tumor biopsies to
analyze molecular inhibition of the epidermal growth factor receptor (EGFR) signaling
pathway, defined as a >= 75% inhibition of phosphorylation of the epidermal growth factor
(EGF) receptor or of its downstream effectors tumor protein (p)44/42 mitogen-activated
protein kinase (MAPK) or protein kinase B (Akt) or as a >= 25% decrease of marker of
proliferation Ki-67 (Ki67) from baseline in either skin or tumor tissue in the majority of
patients.
III. To identify the optimal biological dose (OBD). IV. To describe any antitumor effect
observed.
OUTLINE: This is a phase I, dose-escalation study of erlotinib hydrochloride.
Patients receive cetuximab intravenously (IV) over 1-2 hours on days 1, 8, and 15 and
erlotinib hydrochloride orally (PO) once daily (QD) on days 8-21. Treatment repeats every 21
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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