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Phase II Trial of Erlotinib, Prior to Surgery or Radiation in Patients With Squamous Cell Cancers (SCC) of the Skin

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ClinicalTrials.gov Identifier: NCT01059305
Recruitment Status : Terminated (Lack of primary outcome efficacy.)
First Posted : January 29, 2010
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Skin Cancer
Intervention: Drug: Erlotinib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Process: February 15, 2011 to September 11, 2012. All recruitment done at The University of Texas MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Erlotinib 150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).

Participant Flow:   Overall Study
    Erlotinib
STARTED   10 
COMPLETED   10 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Erlotinib 150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).

Baseline Measures
   Erlotinib 
Overall Participants Analyzed 
[Units: Participants]
 		 10 
Age 
[Units: Years]
Median (Full Range) 		 70 
 (58 to 81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      1  10.0% 
Male      9  90.0% 
Region of Enrollment 
[Units: Participants]
 		 
United States   10 


  Outcome Measures

1.  Primary:   Overall Response   [ Time Frame: 4 weeks ]
  Show Outcome Measure 1


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Bonnie Glisson, MD/Professor, Thoracic/Head & Neck Med Oncology
Organization: The University of Texas (UT) MD Anderson Cancer Center
phone: 713-792-7734
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01059305     History of Changes
Other Study ID Numbers: 2009-0723
NCI-2011-00252 ( Registry Identifier: NCI CTRP )
First Submitted: January 28, 2010
First Posted: January 29, 2010
Results First Submitted: February 16, 2017
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017