Cisplatin and ZD1839 + Re-Irradiation in Recurrent Squamous Cell Cancer of the Head and Neck

NCT ID: NCT00185835

Last Updated: 2010-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30

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 cell cancer of the head and neck.

To study the effects of ZD1839 combined with either cisplatin or radiotherapy on signal transduction pathway gene expression in tumor cells in patients with local-regional recurrent squamous cell cancer of the head and neck using micro array analysis from tumor samples taken at the time of relapse and during treatment.

Conditions

Head and Neck Cancer; Carcinoma, Squamous Cell

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ZD-1839

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society of Clinical Oncology

OTHER

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Stanford University School of Medicine

Principal Investigators

Quynh-Thu Le

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

ENT0012

Identifier Type: -

Identifier Source: secondary_id

NCT00185835

Identifier Type: -

Identifier Source: secondary_id

ENT0012

Identifier Type: -

Identifier Source: org_study_id