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ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00054691
First Posted: February 7, 2003
Last Update Posted: March 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
Results First Submitted: January 28, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Skin Cancer
Intervention: Drug: Iressa

  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: July 2004 to September 2007. All participants recruited 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
Iressa (ZD1839) 250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.

Participant Flow:   Overall Study
    Iressa (ZD1839)
STARTED   40 
COMPLETED   37 
NOT COMPLETED   3 
Unmeasurable Disease                2 
Noncompliant                1 



  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.
Out of 40 participants, 2 participants had unmeasurable disease and 1 participant was noncompliant.

Reporting Groups
  Description
Iressa (ZD1839) 250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.

Baseline Measures
   Iressa (ZD1839) 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age, Customized 
[Units: Years]
Median (Full Range)
 67 
 (37 to 95) 
Gender 
[Units: Participants]
 
Female   10 
Male   30 
Region of Enrollment 
[Units: Participants]
 
United States   40 


  Outcome Measures
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1.  Primary:   Number of Participants With Objective Response (Partial Response, Stable Disease and Progressive Disease)   [ Time Frame: Every 8 weeks till disease progression. ]

2.  Secondary:   Duration of Response   [ Time Frame: Every 8 weeks till disease progression. ]


  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
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  More Information
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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: University of Texas (UT) MD Anderson Cancer Center
phone: 713-792-6363
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00054691     History of Changes
Other Study ID Numbers: ID02-282
First Submitted: February 6, 2003
First Posted: February 7, 2003
Results First Submitted: January 28, 2015
Results First Posted: February 12, 2015
Last Update Posted: March 13, 2015