Status:
COMPLETED
Cisplatin and ZD1839 + Re-Irradiation in Recurrent Squamous Cell Cancer of the Head and Neck
Lead Sponsor:
Stanford University
Collaborating Sponsors:
American Society of Clinical Oncology
AstraZeneca
Conditions:
Head and Neck Cancer
Carcinoma, Squamous Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cel...
Eligibility Criteria
Inclusion
- 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 measurements.
- 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
- 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.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00185835
Start Date
June 1 2002
Last Update
March 29 2010
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305