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

Purpose

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.

Condition	Intervention	Phase
Head and Neck Cancer Carcinoma, Squamous Cell	Drug: ZD-1839 Drug: Cisplatin	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Cisplatin Gefitinib

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

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 [ Time Frame: no known ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To estimate the median and one-year disease-free and overall survival rates of the treated patients. [ Time Frame: one year ] [ Designated as safety issue: No ]
To determine the response rate, duration of response and duration of stable disease in these treated patients. [ Time Frame: not known ] [ Designated as safety issue: No ]
To identify and estimate the incidence rate of acute and late toxicities associated with combined ZD1839, chemotherapy and re-irradiation in patients with recurrent squamous cell cancer of the head and neck. [ Time Frame: no known ] [ Designated as safety issue: Yes ]
To determine the pattern of disease progression in recurrent disease patients treated with this regimen. [ Time Frame: not known ] [ Designated as safety issue: No ]
To assay EGFR pathway-related proteins by IHC and cDNA microarray, and to correlate their baseline expression, as well as changes in expression after therapy, with clinical endpoints including tumor remission and one-year survival. [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	June 2002
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185835

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

American Society of Clinical Oncology

AstraZeneca

Investigators

Principal Investigator:

Quynh-Thu Le

Stanford University

More Information

No publications provided

Responsible Party:	Quynh-Thu Le, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT00185835 History of Changes
Other Study ID Numbers:	ENT0012, ENT0012
Study First Received:	September 12, 2005
Last Updated:	March 25, 2010
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Gefitinib

Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013