Cisplatin and ZD1839 + Re-Irradiation in Recurrent Squamous Cell Cancer of the Head and Neck
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|ClinicalTrials.gov Identifier: NCT00185835|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 29, 2010
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 or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Carcinoma, Squamous Cell||Drug: ZD-1839 Drug: Cisplatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2002|
|Primary Completion Date :||July 2006|
- 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 ]
- To estimate the median and one-year disease-free and overall survival rates of the treated patients. [ Time Frame: one year ]
- To determine the response rate, duration of response and duration of stable disease in these treated patients.
- 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 ]
- To determine the pattern of disease progression in recurrent disease patients treated with this regimen.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185835
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Quynh-Thu Le||Stanford University|