Metastatic Skin Squamous Cell Carcinoma Clinical Trial
Official title:
Phase II Study of Erlotinib, An Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor, in the Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Skin
This phase II trial studies how well erlotinib works in treating participants with skin squamous cell carcinoma that has spread to other places in the body or has come back. Drugs used in chemotherapy, such as erlotinib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
PRIMARY OBJECTIVES:
I. To determine the overall response rate with erlotinib in patients with locoregionally
recurrent or metastatic squamous cell carcinoma of the skin (CSCC) that is not amenable to
curative treatment.
SECONDARY OBJECTIVES:
I. To determine duration of response and duration of stable disease. II. To determine
progression-free and overall survival. III. To determine safety and tolerability of
erlotinib.
EXPLORATORY OBJECTIVES:
I. To correlate baseline expression of estimated glomerular filtration rate (EGFR),
expression of markers of EGFR activation (such as phosphorylated [p] EGFR and pAKT) and
related cell-signaling pathways, and EGFR mutation status with response to erlotinib therapy.
II. To determine the effects of erlotinib on relevant biomarkers of the EGFR pathway in tumor
tissue and in normal skin, and to correlate with response to therapy.
III. To determine if there is a correlation between the development of erlotinib-induced skin
rash and response to therapy.
OUTLINE:
Participants receive erlotinib orally (PO) once daily (QD) in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, participants are followed up every 3 months for up to 2
years.
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