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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00054691
First received: February 6, 2003
Last updated: February 24, 2015
Last verified: February 2015
Results First Received: January 28, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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
No text entered.

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)  
Number of Participants  
[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


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00054691     History of Changes
Other Study ID Numbers: ID02-282
Study First Received: February 6, 2003
Results First Received: January 28, 2015
Last Updated: February 24, 2015
Health Authority: United States: Institutional Review Board