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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gefitinib
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Huntsman Cancer Institute at University of Utah

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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

Outcomes

Primary Outcome Measures

Disease control rate

Secondary Outcome Measures

Biologic parameters
Toxicity
Response

Full Information

First Posted
September 13, 2001
Last Updated
February 8, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00024089
Brief Title
Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
Official Title
A Phase II Study of ZD 1839 (Iressa) in Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive oral gefitinib daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
gefitinib
Primary Outcome Measure Information:
Title
Disease control rate
Secondary Outcome Measure Information:
Title
Biologic parameters
Title
Toxicity
Title
Response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard H. Wheeler, MD
Organizational Affiliation
University of Utah
Official's Role
Study Chair
Facility Information:
Facility Name
Huntsman Cancer Institute at University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

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

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