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| Sponsors and Collaborators: |
University of Utah National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00024089 |
Purpose
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor cells by blocking an enzyme necessary for cell growth.
PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent and/or metastatic head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: gefitinib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of ZD 1839 (Iressa) in Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck |
| Study Start Date: | July 2001 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 50-60 patients (25-30 per stratum) will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary squamous cell cancer of the head and neck that is incurable by surgery or radiotherapy
Stratum I:
Stratum II:
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Utah | |
| Huntsman Cancer Institute at University of Utah | |
| Salt Lake City, Utah, United States, 84112 | |
| Study Chair: | Richard H. Wheeler, MD | University of Utah |
More Information
| Study ID Numbers: | CDR0000068890, UUMC-8429-01, NCI-1701 |
| Study First Received: | September 13, 2001 |
| Last Updated: | December 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00024089 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Nasopharyngeal Carcinoma Laryngeal Carcinoma Squamous Cell Carcinoma Protein Kinase Inhibitors Recurrence Carcinoma Hypopharyngeal Cancer |
Metastatic Squamous Neck Cancer With Occult Primary Head and Neck Neoplasms Epidermoid Carcinoma Carcinoma, Squamous Cell Salivary Gland Diseases Gefitinib |
|
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Head and Neck Neoplasms Enzyme Inhibitors Protein Kinase Inhibitors Gefitinib Pharmacologic Actions |