Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00024089
• Other study ID #: CDR0000068890
• Secondary ID: UUMC-8429-01NCI-
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2001
• Last updated: February 8, 2013
• Start date: July 2001

Study information

• Verified date: November 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent and/or metastatic head and neck cancer. Biological therapies such as gefitinib may interfere with the growth of tumor cells by blocking an enzyme necessary for cell growth.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• gefitinib

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease control rate			No
Secondary	Biologic parameters			No
Secondary	Toxicity			Yes
Secondary	Response			No