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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00242762 |
The primary objective of the study is to evaluate the activity of the combination ZD1839, docetaxel and cisplatin in subjects with recurrent and/or metastatic head and neck cancer by estimating the objective response rate (complete response [CR] and partial response [PR]) at study closure.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: ZD1839 (IRESSA™) Drug: Docetaxel Drug: Cisplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study to Evaluate the Safety and Efficacy of the Combination of ZD1839 (IRESSA™), Docetaxel and Cisplatin in Subjects With Recurrent and/or Metastatic Head and Neck Cancer |
Estimated Enrollment: | 36 |
Study Start Date: | July 2003 |
Study Completion Date: | March 2006 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Research Facility | |
Granada, Spain | |
Research Facility | |
Murcia, Spain | |
Research Facility | |
Madrid, Spain | |
Research Site | |
Sevilla, Spain |
Study Director: | AstraZeneca Spain Medical Director, MD | AstraZeneca |
Study ID Numbers: | 1839IL/0504 |
Study First Received: | October 20, 2005 |
Last Updated: | December 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00242762 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Head and Neck Neoplasms Cancer of Head and Neck Head and Neck Cancer Head Cancer Neck Cancer |
Docetaxel Radiation-Sensitizing Agents Cisplatin Head and Neck Neoplasms |
Protein Kinase Inhibitors Gefitinib Recurrence |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Docetaxel |
Neoplasms Neoplasms by Site Cisplatin Radiation-Sensitizing Agents Head and Neck Neoplasms Therapeutic Uses Gefitinib |