Study of Erlotinib in the Treatment of Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (CSCC) of the Skin
|ClinicalTrials.gov Identifier: NCT01198028|
Recruitment Status : Active, not recruiting
First Posted : September 9, 2010
Last Update Posted : September 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Skin Cancer||Drug: Erlotinib||Phase 2|
Show Detailed Description
|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 2011|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Erlotinib 150 mg by mouth for 8 weeks.
150 mg by mouth for 8 weeks.
- Overall Response Rate (ORR) [ Time Frame: 8 weeks ]Evaluated after 8 weeks, patient considered a non-responder if tumor does not regress to complete or partial response as specified in RECIST v1.1 at that time point. ORR, based on overall response of each evaluable patient, is defined as percentage of patients who achieve an overall response of complete response or partial response in total number of evaluable patients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198028
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Bonnie S. Glisson, MD, BS||M.D. Anderson Cancer Center|