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Phase I-II Study of ZD1839 (IRESSA®), Cisplatin, and External-Beam Radiation Therapy in Patients With Locally Advanced, Non-Metastatic, Squamous Cell Carcinoma of the Head and Neck


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Phase I-II Study of ZD1839 (IRESSA®), Cisplatin, and External-Beam Radiation Therapy in Patients With Locally Advanced, Non-Metastatic, Squamous Cell Carcinoma of the Head and Neck


This is a Phase I-II, open-label, dose-escalation study in subjects with advanced head or
neck cancer. Subjects will receive daily ZD1839 during a course of standard radiation
therapy accompanied by cisplatin.

Subjects are adults with Stage III-IV squamous cell carcinoma of the oral cavity,
oropharynx, larynx, or hypopharynx, who are in medically stable condition, with an Eastern
Cooperative Oncology Group (ECOG) Performance Status of £ 1, stable hepatic and bone marrow
function, and a life expectancy of at least 6 months. Subjects should have no previous
cancer history (with the exception of squamous cell carcinoma of the skin or cervical cancer
in situ) and no prior treatment with radiation, chemotherapy, or definitive surgical
therapy. Subjects in the Phase II portion of the trial must have measurable disease as
defined by RECIST criteria.


Inclusion Criteria:



- Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx,
larynx, or hypopharynx. For the Phase II portion of the study: measurable disease as
based on RECIST criteria.

- Stage III or IV disease, M0.

- Life expectancy > 6 months.

Exclusion Criteria:

- Known severe hypersensitivity to ZD1839 or any of the excipients of this product.

- Other co-existing malignancies or malignancies diagnosed within the last 5 years,
with the exception of squamous cell carcinoma of the skin or cervical cancer in situ.

- Previous treatment with radiation, chemotherapy, or definitive surgical therapy.

- Distant metastatic disease.

- Documented evidence of HIV infection (because the interaction of ZD1839 with Highly
Active Anti-Retroviral Therapy [HAART] is unknown).

- Substance abuse or psychiatric problems that would interfere with compliance.

- Pregnancy or breast-feeding (women of child-bearing potential).

- Treatment with a non-approved or investigational drug within 30 days before Day 1 of
study treatment.

- Any evidence of clinically active interstitial lung disease (patients with chronic
stable radiographic changes who are asymptomatic need not be excluded)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To explore whether the addition of ZD1839 to standard treatment of unresectable head and neck cancers (i.e., cisplatin and radiation therapy) improves the clinical complete response rate (as measured by RECIST criteria).

Principal Investigator

Roger Keresztes, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Food and Drug Administration

Study ID:

0404-218

NCT ID:

NCT00195078

Start Date:

April 2004

Completion Date:

September 2006

Related Keywords:

  • Head and Neck Cancer
  • head and neck cancer
  • squamous cell carcinoma of the oral cavity
  • squamous cell carcinoma of the oropharynx
  • squamous cell carcinoma of the larynx
  • squamous cell carcinoma of the hypopharynx
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location
Weill Medical College of Cornell University New York, New York  10021