Erlotinib in Treating Patients With Recurrent or Metastatic Skin Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT01198028|
Recruitment Status : Active, not recruiting
First Posted : September 9, 2010
Last Update Posted : September 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Skin Squamous Cell Carcinoma Recurrent Skin Squamous Cell Carcinoma||Drug: Erlotinib||Phase 2|
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.
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 10, 2011|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||March 31, 2019|
Experimental: Treatment (erlotinib)
Participants receive erlotinib PO QD in the absence of disease progression or unacceptable toxicity.
- Overall response rate defined as the percentage of patients who achieve an overall response of complete response or partial response in the total number of evaluable patients, assessed by Response Evaluation Criteria in Solid Tumors 1.1 [ Time Frame: After 8 weeks of study therapy ]A Bayesian design based on predictive probability will be implemented.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198028
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Bonnie Glisson||M.D. Anderson Cancer Center|