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 19, 2013
Last verified: February 2013
  Purpose

The goal of this clinical research study is to learn if the drug ZD1839 (Iressa) can shrink or slow the growth of cancer in participants with recurrent and/or metastatic squamous cell cancer (SCC) of the skin. The safety of this drug will also be studied.


Condition Intervention Phase
Skin Cancer
Drug: Iressa
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Participants with Objective Response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Duration of response [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
    Response duration was defined as the time from initial response during therapy to progression of disease.

  • Modulation of biological targets following daily administration of ZD1839 (250 mg) [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2004
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iressa (ZD1839)
Iressa (ZD1839) 250 mg by mouth daily.
Drug: Iressa
250 mg by mouth daily
Other Names:
  • ZD1839
  • Gefitinib

Detailed Description:

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 doctor.

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. Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 100,000/mm**3.
  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 disease).
  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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054691

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
AstraZeneca
Investigators
Principal Investigator: Bonnie S. Glisson, MD, BS M.D. Anderson Cancer Center
  More Information

Additional Information:
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
Last Updated: February 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Skin Cancer
Squamous Cell Carcinoma of the Skin
Gefitinib
ZD1839
Iressa
Epidermal Growth Factor Receptor
EGFR

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Skin Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Skin Diseases
Gefitinib
Mitogens
Antineoplastic Agents
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014