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

NCT00054691 | Completed Phase 2 Results

• 1 other identifier: ID02-282
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Cancer

Keywords

Skin Cancer; Squamous Cell Carcinoma of the Skin; Gefitinib; ZD1839; Iressa; Epidermal Growth Factor Receptor; EGFR

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Objective Response (Partial Response, Stable Disease and Progressive Disease)

  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.

  Every 8 weeks till disease progression.

Secondary Outcomes (1)

• Duration of Response

  Every 8 weeks till disease progression.

Study Arms (1)

Iressa (ZD1839)

EXPERIMENTAL

Iressa (ZD1839) 250 mg by mouth daily.

Drug: Iressa

Interventions

Iressa DRUG

250 mg by mouth daily

Also known as: ZD1839, Gefitinib

Iressa (ZD1839)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent.
• Pathologically confirmed locoregional recurrence and/or metastatic SCC of the skin not amenable to curative therapy (i.e., surgery or radiation).
• Evaluable and/or measurable disease. (Based on Union for International Cancer Control (UICC)/World Health Organization (WHO) Criteria)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• 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.
• Up to one prior chemotherapy regimen.
• At least a 2-week recovery from prior therapy toxicity.
• Age 18 years or older.
• 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.
• Women of childbearing potential and men must be willing to practice acceptable methods of birth control to prevent pregnancy.

You may not qualify if:

• Prior ZD1839 or other Epidermal growth factor receptor (EGFR) inhibiting agents.
• Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma or cervical cancer in situ.
• Any unresolved chronic toxicity greater then Common Terminology Criteria (CTC) grade 2 from previous anticancer therapy.
• Incomplete healing from previous oncologic or other major surgery.
• 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)).
• Absolute neutrophil count (ANC) less than 1,500/mm\*\*3 or platelets less than 100,000/mm\*\*3.
• Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).
• 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).
• 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.
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial.
• Pregnancy or breast feeding (women of child-bearing potential)
• The patient has an uncontrolled seizure disorder or active neurological disease.
• The patient has received any non-approved or investigational agent(s) within 30 days before Day 1 of study treatment.
• Known, severe hypersensitivity to ZD1839 or any of the excipients of this product.
• Any evidence of clinically active Interstitial Lung Disease (ILD) (patients with chronic, stable radiographic changes who are asymptomatic need not be excluded).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• AstraZeneca: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Bonnie Glisson, MD / Professor, Thoracic/Head & Neck Med Oncology
• Organization: University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-6363

Study Officials

• Bonnie S. Glisson, MD, BS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2003
• First Posted: February 7, 2003
• Study Start: May 1, 2004
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 13, 2015
• Results First Posted: February 12, 2015

Record last verified: 2015-02

Locations

US (1)