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A Phase III Randomised, Stratified, Parallel-Group, Multi-Centre, Comparative Study of ZD1839 (Iressa®) 250 Mg and 500 Mg Versus Methotrexate for Previously Treated Patients With Squamous Cell Carcinoma of the Head and Neck


Phase 3
18 Years
N/A
Not Enrolling
Both
Squamous Cell Carcinoma of the Head and Neck

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Trial Information

A Phase III Randomised, Stratified, Parallel-Group, Multi-Centre, Comparative Study of ZD1839 (Iressa®) 250 Mg and 500 Mg Versus Methotrexate for Previously Treated Patients With Squamous Cell Carcinoma of the Head and Neck


Inclusion Criteria:



- Histological confirmation of evidence of squamous cell carcinoma of the head and
neck.

- Tumors have progressed after primary treatment with radiation or chemoradiation and
have failed to respond to at least one course of standard platinum-based
chemotherapy.

- Tumors have progressed after primary treatment with radiation or chemoradiation and
are considered unsuitable for platinum-based chemotherapy.

Exclusion Criteria:

- Carcinomas of the post-nasal space, thyroid, sinus or salivary gland tumors.

- Isolated recurrent disease that may be amenable to local therapy; e.g., surgical
intervention or radiation therapy.

- Known severe hypersensitivity to ZD1839, Methotrexate or any of the excipients of
these products.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Compare ZD1839 versus methotrexate in overall survival

Principal Investigator

AstraZeneca Iressa Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

1839IL/0704

NCT ID:

NCT00206219

Start Date:

November 2003

Completion Date:

September 2007

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck
  • Squamous cell carcinoma of the head and neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Research SiteAlabaster, Alabama  
Research SiteMesa, Arizona  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteArlington Heights, Illinois  
Research SiteAmes, Iowa  
Research SiteAshland, Kentucky  
Research SiteBaton Rouge, Louisiana  
Research SiteBangor, Maine  
Research SiteBaltimore, Maryland  
Research SiteBattle Kreek, Michigan  
Research SiteGrand Island, Nebraska  
Research SiteBelleville, New Jersey  
Research SiteAlbany, New York  
Research SiteEnid, Oklahoma  
Research SiteAllentown, Pennsylvania  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington  
Research SiteAppleton, Wisconsin