Trial Outcomes & Findings for ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin (NCT NCT00054691)
NCT ID: NCT00054691
Last Updated: 2015-03-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Every 8 weeks till disease progression.
Results posted on
2015-03-13
Participant Flow
Recruitment period: July 2004 to September 2007. All participants recruited at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
Iressa (ZD1839)
250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Iressa (ZD1839)
250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
|
|---|---|
|
Overall Study
Unmeasurable Disease
|
2
|
|
Overall Study
Noncompliant
|
1
|
Baseline Characteristics
ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin
Baseline characteristics by cohort
| Measure |
Iressa (ZD1839)
n=40 Participants
250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
|
|---|---|
|
Age, Customized
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 8 weeks till disease progression.Population: Out of 40 participants, 2 participants had unmeasurable disease and 1 participant was noncompliant.
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.
Outcome measures
| Measure |
Iressa (ZD1839)
n=37 Participants
250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
|
|---|---|
|
Number of Participants With Objective Response (Partial Response, Stable Disease and Progressive Disease)
Stable Disease
|
14 participants
|
|
Number of Participants With Objective Response (Partial Response, Stable Disease and Progressive Disease)
Partial Response
|
4 participants
|
|
Number of Participants With Objective Response (Partial Response, Stable Disease and Progressive Disease)
Progressive Disease
|
19 participants
|
SECONDARY outcome
Timeframe: Every 8 weeks till disease progression.Population: Out of 40 participants, 19 participants had progressive disease, 2 participants had unmeasurable disease and 1 participant was noncompliant.
Response duration was defined as the time from initial response during therapy to progression of disease.
Outcome measures
| Measure |
Iressa (ZD1839)
n=18 Participants
250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
|
|---|---|
|
Duration of Response
|
24.8 months
Interval 0.9 to 47.2
|
Adverse Events
Iressa (ZD1839)
Serious events: 17 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Iressa (ZD1839)
n=40 participants at risk
250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
|
|---|---|
|
Vascular disorders
Pulmonary Embolism
|
7.5%
3/40 • Number of events 4 • Reporting Period: November 2007 to September 2009.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Musculoskeletal and connective tissue disorders
Pseudotumor Cerebri
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Gastrointestinal disorders
Severe Gastrointestinal Bleeding (Melena)
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Immune system disorders
Pharyngeal Mucositis
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Immune system disorders
Stomatitis
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leptomeningeal Metastases
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Blood and lymphatic system disorders
Bone Marrow Depression
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Vascular disorders
Deep Vein Thrombosis (Legs)
|
5.0%
2/40 • Number of events 2 • Reporting Period: November 2007 to September 2009.
|
|
Injury, poisoning and procedural complications
Ruptured Superior Vena Cava
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Vascular disorders
Chronic Pulmonary Thromboembolism
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Hepatobiliary disorders
Hepatic Function Disorder
|
5.0%
2/40 • Number of events 2 • Reporting Period: November 2007 to September 2009.
|
|
Blood and lymphatic system disorders
Blood Creatinine, Increased
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Cardiac disorders
Worsening Hypertension
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Renal and urinary disorders
Worsening Renal Function
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Vascular disorders
Thrombosis of Goretex
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
General disorders
Worsening of Migraine
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Infections and infestations
Interstitial Pneumonia
|
5.0%
2/40 • Number of events 2 • Reporting Period: November 2007 to September 2009.
|
|
Respiratory, thoracic and mediastinal disorders
Odynophagia
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukemia
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
General disorders
Weakness
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Infections and infestations
Cellulitis
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
Other adverse events
| Measure |
Iressa (ZD1839)
n=40 participants at risk
250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
|
|---|---|
|
Skin and subcutaneous tissue disorders
ACNE
|
7.5%
3/40 • Number of events 3 • Reporting Period: November 2007 to September 2009.
|
|
General disorders
ALLERGIC RHINITIS
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
5.0%
2/40 • Number of events 2 • Reporting Period: November 2007 to September 2009.
|
|
Hepatobiliary disorders
ALT, SGPT
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Blood and lymphatic system disorders
ANEMIA
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Psychiatric disorders
ANOREXIA
|
12.5%
5/40 • Number of events 5 • Reporting Period: November 2007 to September 2009.
|
|
Hepatobiliary disorders
AST, SGOT
|
5.0%
2/40 • Number of events 2 • Reporting Period: November 2007 to September 2009.
|
|
Hepatobiliary disorders
BUN INCREASE
|
7.5%
3/40 • Number of events 3 • Reporting Period: November 2007 to September 2009.
|
|
Immune system disorders
CHEILITIS
|
5.0%
2/40 • Number of events 2 • Reporting Period: November 2007 to September 2009.
|
|
Gastrointestinal disorders
CONSTIPATION
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.0%
2/40 • Number of events 2 • Reporting Period: November 2007 to September 2009.
|
|
Hepatobiliary disorders
CREATININE INCREASE
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
General disorders
DEHYDRATION
|
5.0%
2/40 • Number of events 2 • Reporting Period: November 2007 to September 2009.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN
|
10.0%
4/40 • Number of events 4 • Reporting Period: November 2007 to September 2009.
|
|
Gastrointestinal disorders
DIARRHEA
|
55.0%
22/40 • Number of events 22 • Reporting Period: November 2007 to September 2009.
|
|
General disorders
DIZZINESS
|
5.0%
2/40 • Number of events 2 • Reporting Period: November 2007 to September 2009.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
15.0%
6/40 • Number of events 6 • Reporting Period: November 2007 to September 2009.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
10.0%
4/40 • Number of events 4 • Reporting Period: November 2007 to September 2009.
|
|
Vascular disorders
EDEMA: HEAD AND NECK
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
5.0%
2/40 • Number of events 2 • Reporting Period: November 2007 to September 2009.
|
|
General disorders
FATIGUE
|
40.0%
16/40 • Number of events 16 • Reporting Period: November 2007 to September 2009.
|
|
General disorders
FEVER WITHOUT NEUTROPENIA
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Nervous system disorders
HEADACHE
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Gastrointestinal disorders
HEARTBURN
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HEMORRHAGE
|
5.0%
2/40 • Number of events 2 • Reporting Period: November 2007 to September 2009.
|
|
Endocrine disorders
HYPERGLYCEMIA
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Blood and lymphatic system disorders
HYPERKALEMIA
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Skin and subcutaneous tissue disorders
HYPERPIGMENTATION
|
7.5%
3/40 • Number of events 3 • Reporting Period: November 2007 to September 2009.
|
|
Hepatobiliary disorders
HYPERURICEMIA
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
15.0%
6/40 • Number of events 6 • Reporting Period: November 2007 to September 2009.
|
|
Infections and infestations
INFECTION
|
7.5%
3/40 • Number of events 3 • Reporting Period: November 2007 to September 2009.
|
|
Blood and lymphatic system disorders
INTERNATIONAL NORMALIZED RATIO
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Infections and infestations
KERATITIS
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Immune system disorders
LEUKOCYTES
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Metabolism and nutrition disorders
METABOLIC
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Immune system disorders
MUCOSITIS
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Skin and subcutaneous tissue disorders
NAIL CHANGES
|
5.0%
2/40 • Number of events 2 • Reporting Period: November 2007 to September 2009.
|
|
General disorders
NAUSEA
|
12.5%
5/40 • Number of events 5 • Reporting Period: November 2007 to September 2009.
|
|
Eye disorders
OCULAR/VISUAL
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
General disorders
PAIN
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Gastrointestinal disorders
PAIN (ABDOMEN NOS)
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Musculoskeletal and connective tissue disorders
PAIN (JOINT)
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Respiratory, thoracic and mediastinal disorders
PAIN (ORAL CAVITY)
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Gastrointestinal disorders
PAIN (STOMACH)
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
12.5%
5/40 • Number of events 5 • Reporting Period: November 2007 to September 2009.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMA
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
65.0%
26/40 • Number of events 26 • Reporting Period: November 2007 to September 2009.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Nervous system disorders
SYNCOPE (FAINTING)
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Nervous system disorders
VERTIGO
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Infections and infestations
VIRAL INFECTION
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Gastrointestinal disorders
VOMITING
|
2.5%
1/40 • Number of events 1 • Reporting Period: November 2007 to September 2009.
|
|
Eye disorders
WATERY EYES
|
5.0%
2/40 • Number of events 2 • Reporting Period: November 2007 to September 2009.
|
Additional Information
Bonnie Glisson, MD / Professor, Thoracic/Head & Neck Med Oncology
University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-6363
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place