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A Phase II Study of ZD 1839 (Iressa) in Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

A Phase II Study of ZD 1839 (Iressa) in Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck


OBJECTIVES:

I. Determine the disease control rate, in terms of complete response, partial response, and
stable disease for at least 4 months, in patients with recurrent and/or metastatic squamous
cell cancer of the head and neck treated with gefitinib.

II. Determine the effect of this drug on epidermal growth factor receptor phosphorylation
and expression of selected genes in these patients.

III. Determine the toxic effects of this drug in these patients.

OUTLINE: Patients are stratified as delineated in the Disease Characteristics.

Patients receive oral gefitinib daily. Treatment repeats every 28 days in the absence of
disease progression or unacceptable toxicity.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed primary squamous cell cancer of the head
and neck that is incurable by surgery or radiotherapy

- Stratum I:

- Failed surgery and/or radiotherapy and received no prior systemic
chemotherapy for recurrent disease OR

- Recurrent disease at least 6 months after prior multimodal primary therapy
including neoadjuvant or concurrent chemotherapy OR

- Metastatic disease at initial diagnosis and received no prior chemotherapy

- Stratum II:

- No more than 1 prior chemotherapy regimen for recurrent disease OR

- Recurrent disease within 6 months after prior primary therapy that included
chemotherapy

- Measurable disease

- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

- Clear clinical evidence of progression or biopsy-proven residual cancer required
if only site of measurable disease is in a previously irradiated field

- No known brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy:

- More than 3 months

Hematopoietic:

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin normal (no greater than 1.5 times upper limit of normal [ULN] if liver
metastases present)

- AST/ALT no greater than 2.5 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Other:

- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- No other uncontrolled concurrent illness

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- No prior allergic reactions attributed to compounds of similar chemical or biologic
composition to gefitinib

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior therapy with agents that target epidermal growth factor receptors

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered

Endocrine therapy:

- No concurrent tamoxifen

Radiotherapy:

- Prior radiotherapy as primary or secondary treatment allowed

- At least 4 weeks since prior radiotherapy and recovered

Surgery:

- Prior surgery as primary or secondary treatment allowed

- At least 4 weeks since prior major surgery

Other:

- No other concurrent investigational agents

- No concurrent combination antiretroviral therapy for HIV

- No concurrent 3A4 inhibitors (e.g., ketoconazole, erythromycin, verapamil)

- No concurrent drugs with known corneal toxicity (e.g., chlorpromazine, amiodarone,
chloroquine)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease control rate

Safety Issue:

No

Principal Investigator

Richard H. Wheeler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Utah

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068890

NCT ID:

NCT00024089

Start Date:

July 2001

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • recurrent metastatic squamous neck cancer with occult primary
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • salivary gland squamous cell carcinoma
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112