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

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ClinicalTrials.gov Identifier: NCT00054691
Recruitment Status : Completed
First Posted : February 7, 2003
Results First Posted : February 12, 2015
Last Update Posted : March 13, 2015
Sponsor:
Collaborator:
AstraZeneca
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: Iressa
Enrollment 40
Recruitment Details Recruitment period: July 2004 to September 2007. All participants recruited at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Iressa (ZD1839)
Hide Arm/Group Description 250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
Period Title: Overall Study
Started 40
Completed 37
Not Completed 3
Reason Not Completed
Unmeasurable Disease             2
Noncompliant             1
Arm/Group Title Iressa (ZD1839)
Hide Arm/Group Description 250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
Out of 40 participants, 2 participants had unmeasurable disease and 1 participant was noncompliant.
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
67
(37 to 95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
10
  25.0%
Male
30
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title Number of Participants With Objective Response (Partial Response, Stable Disease and Progressive Disease)
Hide Description Responses were assessed according to the Union Internationale Contre le Cancer (UICC) / World Health Organization (WHO) criteria. Objective response (measurable response) defined as: Partial response (PR): Applies only to participants with at least 1 measurable lesion; >/=50% decrease under baseline in sum of products of perpendicular diameters of all measurable lesions. Stable Disease (SD): No progression of evaluable disease and/or no new lesions. Progressive Disease (PD): 50% increase or an increase of 10 cm2 (whichever is smaller) in the sum of products of all measurable lesions overall smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease.
Time Frame Every 8 weeks till disease progression.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Out of 40 participants, 2 participants had unmeasurable disease and 1 participant was noncompliant.
Arm/Group Title Iressa (ZD1839)
Hide Arm/Group Description:
250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: participants
Stable Disease 14
Partial Response 4
Progressive Disease 19
2.Secondary Outcome
Title Duration of Response
Hide Description Response duration was defined as the time from initial response during therapy to progression of disease.
Time Frame Every 8 weeks till disease progression.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Out of 40 participants, 19 participants had progressive disease, 2 participants had unmeasurable disease and 1 participant was noncompliant.
Arm/Group Title Iressa (ZD1839)
Hide Arm/Group Description:
250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
Overall Number of Participants Analyzed 18
Median (Full Range)
Unit of Measure: months
24.8
(0.9 to 47.2)
Time Frame Reporting Period: November 2007 to September 2009.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Iressa (ZD1839)
Hide Arm/Group Description 250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
All-Cause Mortality
Iressa (ZD1839)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Iressa (ZD1839)
Affected / at Risk (%) # Events
Total   17/40 (42.50%)    
Blood and lymphatic system disorders   
Anaemia  1  1/40 (2.50%)  1
Bone Marrow Depression  1  1/40 (2.50%)  1
Blood Creatinine, Increased  1  1/40 (2.50%)  1
Cardiac disorders   
Worsening Hypertension  1  1/40 (2.50%)  1
Gastrointestinal disorders   
Abdominal Pain  1  1/40 (2.50%)  1
Intestinal Ischaemia  1  1/40 (2.50%)  1
Severe Gastrointestinal Bleeding (Melena)  1  1/40 (2.50%)  1
General disorders   
Worsening of Migraine  1  1/40 (2.50%)  1
Weakness  1  1/40 (2.50%)  1
Hepatobiliary disorders   
Hepatic Function Disorder  1  2/40 (5.00%)  2
Immune system disorders   
Pharyngeal Mucositis  1  1/40 (2.50%)  1
Stomatitis  1  1/40 (2.50%)  1
Infections and infestations   
Interstitial Pneumonia  1  2/40 (5.00%)  2
Cellulitis  1  1/40 (2.50%)  1
Injury, poisoning and procedural complications   
Ruptured Superior Vena Cava  1  1/40 (2.50%)  1
Musculoskeletal and connective tissue disorders   
Pseudotumor Cerebri  1  1/40 (2.50%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Leptomeningeal Metastases  1  1/40 (2.50%)  1
Acute Myeloid Leukemia  1  1/40 (2.50%)  1
Renal and urinary disorders   
Worsening Renal Function  1  1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural Effusion  1  1/40 (2.50%)  1
Odynophagia  1  1/40 (2.50%)  1
Vascular disorders   
Pulmonary Embolism  1  3/40 (7.50%)  4
Deep Vein Thrombosis (Legs)  1  2/40 (5.00%)  2
Chronic Pulmonary Thromboembolism  1  1/40 (2.50%)  1
Thrombosis of Goretex  1  1/40 (2.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Iressa (ZD1839)
Affected / at Risk (%) # Events
Total   40/40 (100.00%)    
Blood and lymphatic system disorders   
ANEMIA  1  1/40 (2.50%)  1
HEMOGLOBIN  1  1/40 (2.50%)  1
HYPERKALEMIA  1  1/40 (2.50%)  1
INTERNATIONAL NORMALIZED RATIO  1  1/40 (2.50%)  1
Endocrine disorders   
HYPERGLYCEMIA  1  1/40 (2.50%)  1
Eye disorders   
OCULAR/VISUAL  1  1/40 (2.50%)  1
WATERY EYES  1  2/40 (5.00%)  2
Gastrointestinal disorders   
CONSTIPATION  1  1/40 (2.50%)  1
DIARRHEA  1  22/40 (55.00%)  22
HEARTBURN  1  1/40 (2.50%)  1
PAIN (ABDOMEN NOS)  1  1/40 (2.50%)  1
PAIN (STOMACH)  1  1/40 (2.50%)  1
VOMITING  1  1/40 (2.50%)  1
General disorders   
ALLERGIC RHINITIS  1  1/40 (2.50%)  1
DEHYDRATION  1  2/40 (5.00%)  2
DIZZINESS  1  2/40 (5.00%)  2
FATIGUE  1  16/40 (40.00%)  16
FEVER WITHOUT NEUTROPENIA  1  1/40 (2.50%)  1
NAUSEA  1  5/40 (12.50%)  5
PAIN  1  1/40 (2.50%)  1
Hepatobiliary disorders   
ALT, SGPT  1  1/40 (2.50%)  1
AST, SGOT  1  2/40 (5.00%)  2
BUN INCREASE  1  3/40 (7.50%)  3
CREATININE INCREASE  1  1/40 (2.50%)  1
HYPERURICEMIA  1  1/40 (2.50%)  1
Immune system disorders   
CHEILITIS  1  2/40 (5.00%)  2
LEUKOCYTES  1  1/40 (2.50%)  1
MUCOSITIS  1  1/40 (2.50%)  1
Infections and infestations   
INFECTION  1  3/40 (7.50%)  3
KERATITIS  1  1/40 (2.50%)  1
VIRAL INFECTION  1  1/40 (2.50%)  1
Metabolism and nutrition disorders   
HYPOCALCEMIA  1  1/40 (2.50%)  1
HYPOKALEMIA  1  1/40 (2.50%)  1
HYPOMAGNESEMIA  1  6/40 (15.00%)  6
METABOLIC  1  1/40 (2.50%)  1
Musculoskeletal and connective tissue disorders   
PAIN (JOINT)  1  1/40 (2.50%)  1
Nervous system disorders   
HEADACHE  1  1/40 (2.50%)  1
MEMORY IMPAIRMENT  1  1/40 (2.50%)  1
SYNCOPE (FAINTING)  1  1/40 (2.50%)  1
VERTIGO  1  1/40 (2.50%)  1
Psychiatric disorders   
ANOREXIA  1  5/40 (12.50%)  5
Respiratory, thoracic and mediastinal disorders   
COUGH  1  2/40 (5.00%)  2
DYSPNEA  1  4/40 (10.00%)  4
PULMONARY HEMORRHAGE  1  2/40 (5.00%)  2
PAIN (ORAL CAVITY)  1  1/40 (2.50%)  1
SINUS CONGESTION  1  1/40 (2.50%)  1
Skin and subcutaneous tissue disorders   
ACNE  1  3/40 (7.50%)  3
ALOPECIA  1  2/40 (5.00%)  2
DERMATITIS  1  1/40 (2.50%)  1
DERMATOLOGY/SKIN  1  4/40 (10.00%)  4
DRY SKIN  1  6/40 (15.00%)  6
ERYTHEMA MULTIFORME  1  2/40 (5.00%)  2
HYPERPIGMENTATION  1  3/40 (7.50%)  3
NAIL CHANGES  1  2/40 (5.00%)  2
PRURITUS  1  5/40 (12.50%)  5
RASH ERYTHEMA  1  1/40 (2.50%)  1
RASH/DESQUAMATION  1  26/40 (65.00%)  26
Vascular disorders   
EDEMA: HEAD AND NECK  1  1/40 (2.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
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
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