NCT01198028

Erlotinib in Treating Patients With Recurrent or Metastatic Skin Squamous Cell Carcinoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Skin Squamous Cell Carcinoma
• Recurrent Skin Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Erlotinib	Given PO

Timeline

• Start date: 2011-03-10
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2010-09-09
• Last updated: 2020-06-11
• Results posted: 2020-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study