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A Phase II Stdy of ZD 1839 in Recurrent and/or Metastatic Squamous Cell Carcinoma 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 Stdy of ZD 1839 in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck


OBJECTIVES: I. Determine the activity of ZD 1839 in patients with metastatic or recurrent
squamous cell carcinoma of the head and neck. II. Determine the effectiveness of this
regimen in these patients. III. Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive oral ZD 1839 once daily on days 1-28.
Treatment repeats every 28 days in the absence of disease progression or unacceptable
toxicity. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within 1-2
years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or recurrent
squamous cell carcinoma of the head and neck that is incurable by surgery or radiotherapy
At least 1 lesion measurable in at least 1 dimension At least 20 mm by conventional
techniques OR At least 10 mm by CT scan No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 60-100%
Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute
neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin
normal AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine no
greater than 1.5 mg/dL Cardiovascular: No symptomatic congestive heart failure No unstable
angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy
test Fertile patients must use effective contraception No history of allergic reactions to
compounds of similar chemical or biological composition to ZD 1839 No active infection No
other uncontrolled illness No psychiatric illness or social situation that would preclude
study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior epidermal growth factor
receptor-based therapy for recurrent disease Chemotherapy: No more than 1 prior adjuvant
or neoadjuvant chemotherapy and/or chemoradiotherapy regimen At least 4 weeks since prior
chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: Not
specified Radiotherapy: See Disease Characteristics See Chemotherapy At least 4 weeks
since prior radiotherapy and recovered Surgery: See Disease Characteristics Other: No more
than 1 prior regimen for recurrent disease No other concurrent investigational agents No
concurrent combination antiretroviral therapy for HIV

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Early response rates of ZD1839 in head and neck tumors

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

Everett Vokes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

10869A

NCT ID:

NCT00015964

Start Date:

March 2001

Completion Date:

July 2005

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
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Loyola University Medical CenterMaywood, Illinois  60153
Ingalls Memorial HospitalHarvey, Illinois  60426
Evanston Northwestern Health CareEvanston, Illinois  60201
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
Cancer Care Specialists of Central Illinois, S.C.Decatur, Illinois  62526
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Fort Wayne Medical Oncology and Hematology, Inc.Fort Wayne, Indiana  46885-5099
Michiana Hematology/Oncology P.C.South Bend, Indiana  46617
Oncology Care Associates, P.L.L.C.Saint Joseph, Michigan  49085
Columbia LaGrange Memorial HospitalLaGrange, Illinois  60525