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Phase I Study of Cisplatin And ZD1839 (IRESSA®) in Combination With Concomitant Re-Irradiation in Patients With Loco-Regional Recurrent Squamous Cell Cancer of the Head and Neck

Phase 1
18 Years
Not Enrolling
Head and Neck Cancer, Carcinoma, Squamous Cell

Thank you

Trial Information

Phase I Study of Cisplatin And ZD1839 (IRESSA®) in Combination With Concomitant Re-Irradiation in Patients With Loco-Regional Recurrent Squamous Cell Cancer of the Head and Neck

Inclusion Criteria:

- Patients must have pathologically confirmed recurrence (reappearance
of previously cleared) squamous cell cancer primary in the upper aerodigestive tract or a
second squamous cell primary (excluding nasopharynx or salivary gland tumors). Patients
may have experienced more than one recurrence as long as the first recurrence occurred
greater than or equal to 6 months following the end of the prior RT.

- The recurrence or second primary must have defined bi- or uni-dimensional

- Recurrence or second primary must be confined to the head and neck above the
clavicles (loco-regional recurrence).

- The patient must not be a candidate for complete surgical resection. The previous
irradiation must not exceed a maximum of 75 Gy.

- The entire tumor volume must be included in a treatment field that limits the total
spinal cord dose to 50 Gy (prior RT and anticipated RT).

- Patients must be at least 6 months from prior radiation therapy.

- Patients may have received prior chemotherapy as a component of their primary
treatment, but not for recurrent disease.

- Zubrod performance status 0-1.

- Granulocytes greater than or equal to 1500/mm3, platelets greater than or equal to
100,000/mm3, serum bilirubin less than or equal to 1.5 mg/dl, creatinine less than or
equal to 1.5 mg/dl within 2 weeks prior to registration.

- LFT's less than or equal to 2 x normal (SGOT/SGPT/Alkaline Phosphatase). If greater
than 2 x normal, liver ultrasound or CT is required to exclude metastases. If
negative for metastases, patients are eligible.

- Must be able to submit previous radiation records, including simulation and portal
films, in order to assure that cord tolerance is not exceeded.

- Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:- Primary in the nasopharynx or the salivary gland.

- Intercurrent medical illnesses which would impair patient tolerance to therapy or
limit survival.

- A history of allergic reactions attributed to compounds of similar chemical or
biologic composition to ZD1839 or other agents used in study.

- Pregnant and nursing women are excluded because of the potential teratogenic effects
and potential unknown effects on nursing newborns.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD 1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cell cancer of the head and neck

Outcome Time Frame:

no known

Safety Issue:


Principal Investigator

Quynh-Thu Le

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

June 2002

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Carcinoma, Squamous Cell
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms



Stanford University School of MedicineStanford, California  94305-5317