Conditions: Metastatic Skin Squamous Cell Carcinoma Recurrent Skin Squamous Cell Carcinoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 42
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Participants receive erlotinib PO QD in the absence of disease progression or unacceptable toxicity.

Interventions: intervention 1: Erlotinib
Intervention descriptions: intervention 1: Given PO

Protocol document:
Prot_SAP_000.pdf: