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A Phase II Study of ZD1839 (Iressa), Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor, in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Skin

Phase 2
18 Years
Not Enrolling
Skin Cancer

Thank you

Trial Information

A Phase II Study of ZD1839 (Iressa), Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor, in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Skin

ZD1839 is a new drug that may slow or stop cell growth in humans.

Epidermal growth factor receptor (EGFR) may be involved in certain types of cancer,
including squamous cell carcinoma of the skin. When EGFR is stimulated, a series of
chemical reactions starts that results in a tumor being "told" to grow. ZD1839 tries to
stop these reactions by blocking EGFR. This may stop tumors from growing.

In this study, participants will take ZD1839 by mouth daily. Once the treatment has
started, participants will return to the clinic before every treatment cycle (every 4 weeks)
for the first 4 months then every 8 weeks thereafter. At these visits, participants will
have a physical exam and blood tests will be performed. About 2-4 teaspoons of blood will
be drawn at each visit. The doctor will also check on how participants are tolerating
ZD1839 (side effects). Every 8 weeks, participants will have their tumor evaluated by
radiographic scans. This may include either a CT or MRI and a chest X-ray.

During treatment, participants should not take any other medication, including
non-prescription drugs such as aspirin or herbal products without the approval of their

Participants will continue taking the trial drug until the tumor grows, a severe side effect
occurs, they withdraw consent, or the study is closed. The study will be closed 12 months
after the last participant is enrolled.

This is an investigational study. The FDA has approved ZD1839 for the treatment of advanced
lung cancer, but the FDA has authorized ZD1839 for research only in the treatment of skin
cancer. About 40 participants will take part in this study. All will be enrolled at M.D.

Inclusion Criteria:

1. Provision of written informed consent.

2. Pathologically confirmed locoregional recurrence and/or metastatic SCC of the skin
not amenable to curative therapy (i.e., surgery or radiation).

3. Evaluable and/or measurable disease. (Based on Union for International Cancer Control
(UICC)/World Health Organization (WHO) Criteria)

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

5. Adequate hematologic function as defined by an absolute neutrophil count >=
1,500/mm3, a platelet count >= 100,000/mm3, a white blood count (WBC) >= 3,000/ mm3,
and a hemoglobin level of >= 9 g/dl.

6. Up to one prior chemotherapy regimen.

7. At least a 2-week recovery from prior therapy toxicity.

8. Age 18 years or older.

9. Disease free from a previously treated malignancy, other than the disease under
study, for greater than 3 years. Patients with a history of a previous basal cell
carcinoma of the skin or pre-invasive carcinoma of the cervix, completely resected
breast cancer will not be excluded.

10. Women of childbearing potential and men must be willing to practice acceptable
methods of birth control to prevent pregnancy.

Exclusion Criteria:

1. Prior ZD1839 or other Epidermal growth factor receptor (EGFR) inhibiting agents.

2. Other co-existing malignancies or malignancies diagnosed within the last 3 years with
the exception of basal cell carcinoma or cervical cancer in situ.

3. Any unresolved chronic toxicity greater then Common Terminology Criteria (CTC) grade
2 from previous anticancer therapy.

4. Incomplete healing from previous oncologic or other major surgery.

5. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, St John's
Wort. Patients taking anticoagulants must have coagulation parameters followed (i.e.,
Prothrombin time (PT) or Partial thromboplastin time (PTT)).

6. Absolute neutrophil count (ANC) less than 1,500/mm**3 or platelets less than

7. Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).

8. In the opinion of the investigator, any evidence of severe or uncontrolled systemic
disease, (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal

9. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5
times the ULRR if no demonstrable liver metastases or greater than 5 times the Upper
Limit of the Reference Range (ULRR) in the presence of liver metastases.

10. Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the patient to participate in the trial.

11. Pregnancy or breast feeding (women of child-bearing potential)

12. The patient has an uncontrolled seizure disorder or active neurological disease.

13. The patient has received any non-approved or investigational agent(s) within 30 days
before Day 1 of study treatment.

14. Known, severe hypersensitivity to ZD1839 or any of the excipients of this product.

15. Any evidence of clinically active Interstitial Lung Disease (ILD) (patients with
chronic, stable radiographic changes who are asymptomatic need not be excluded).

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Objective Response

Outcome Description:

Participants with objective response (measurable response), defined as: Complete response (CR): Complete disappearance of all measurable and evaluable disease; Partial Response Partial response (PR): Applies only to participants with at least 1 measurable lesion; >/= to 50% decrease under baseline in sum of products of perpendicular diameters of all measurable lesions. For either response - No progression of evaluable disease. No new lesions. All measurable and evaluable lesions and sites assessed using same techniques as baseline. Tumor response assessed at completion of one course ZD1839 therapy (4 weeks), with repeat assessment 4 weeks later.

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Bonnie S. Glisson, MD, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2004

Completion Date:

October 2012

Related Keywords:

  • Skin Cancer
  • Skin Cancer
  • Squamous Cell Carcinoma of the Skin
  • Gefitinib
  • ZD1839
  • Iressa
  • Epidermal Growth Factor Receptor
  • EGFR
  • Carcinoma
  • Skin Neoplasms
  • Carcinoma, Squamous Cell
  • Carcinoma, Basal Cell
  • Carcinoma, Basosquamous



UT MD Anderson Cancer Center Houston, Texas  77030