Gefitinib in Treating Patients Who Are Undergoing Surgery and/or Radiation Therapy for Locally Advanced or Recurrent Squamous Cell Skin Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00126555
First received: August 2, 2005
Last updated: December 16, 2014
Last verified: September 2014
Results First Received: December 16, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Skin Cancer
Squamous Cell Carcinoma of the Skin
Interventions: Drug: Gefitinib
Radiation: Radiotherapy
Procedure: Conventional surgery
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: April 08, 2005 to March 13, 2008. All participants were recruited at the University of Texas (UT) MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 23 participants enrolled, one participant who was not evaluable for response withdrew before beginning treatment and is included the study demographics.

Reporting Groups
  Description
Gefitinib, Radiotherapy, Surgery Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.

Participant Flow:   Overall Study
    Gefitinib, Radiotherapy, Surgery  
STARTED     23  
COMPLETED     17  
NOT COMPLETED     6  
Withdrawal by Subject                 1  
Adverse Event                 2  
Progressive Disease                 3  



  Baseline Characteristics
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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.
Of the 23 participants enrolled, one participant who was not evaulable for response withdrew before beginning treatment.

Reporting Groups
  Description
Gefitinib, Radiotherapy, Surgery Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.

Baseline Measures
    Gefitinib, Radiotherapy, Surgery  
Number of Participants  
[units: participants]
  23  
Age [1]
[units: years]
Median ( Full Range )
  65  
  ( 27 to 93 )  
Gender  
[units: participants]
 
Female     6  
Male     17  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     2  
Not Hispanic or Latino     21  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     21  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     23  
[1] Demographics are reported as consolidated information for both stratum.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Early Progression Rate   [ Time Frame: Baseline to 60 days, up to 2 courses of induction therapy ]

2.  Primary:   Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3)   [ Time Frame: Up to 5 years ]

3.  Primary:   Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3)   [ Time Frame: Up to 5 years ]

4.  Secondary:   Clinical Response According to Response Evaluation Criteria In Solid Tumors (RECIST)   [ Time Frame: Up to 5 years ]

5.  Post-Hoc:   Participant Treatment Following Induction Therapy   [ Time Frame: Following 60 days of Gefitinib induction treatment ]

6.  Primary:   Feasibility Rate   [ Time Frame: Up to 7 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Frequency and Timing of Local and Distant Failures   [ Time Frame: From study entry to first documented local recurrence or last patient contact, assessed up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Change in Epidermal Growth Factor Receptor (EGFR) and Phospho-Akt Expression   [ Time Frame: From baseline to up to 30 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Randal S. Weber, MD / Professor
Organization: University of Texas MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00126555     History of Changes
Other Study ID Numbers: NCI-2012-02893, 2004-0204
Study First Received: August 2, 2005
Results First Received: December 16, 2014
Last Updated: December 16, 2014
Health Authority: United States: Food and Drug Administration