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Sponsored by: |
Case Comprehensive Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00352105 |
RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cisplatin, fluorouracil, and gefitinib together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of giving cisplatin, fluorouracil, and gefitinib together with hyperfractionated radiation therapy and to see how well they work in treating patients with locally advanced head and neck cancer.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: cisplatin Drug: fluorouracil Drug: gefitinib Radiation: hyperfractionated radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Trial of Concurrent Chemotherapy and ZD1839 (IRESSA) With Hyperfractionated Radiation Therapy, Followed by Maintenance ZD1839 (IRESSA) for Patients With Locally Advanced Squamous Cell Head and Neck Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | April 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IV continuously over 96 hours and cisplatin IV continuously over 96 hours on days 1-4 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3-6 months.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary* squamous cell carcinoma of the head and neck region, excluding any of the following:
Locoregionally confined stage III or IV disease
PATIENT CHARACTERISTICS:
No evidence of clinically active interstitial lung disease
PRIOR CONCURRENT THERAPY:
No concurrent CYP3A4 inducers, including any of the following:
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 |
Study Chair: | David J. Adelstein, MD | The Cleveland Clinic |
Study ID Numbers: | CDR0000482375, CASE-CCF-5842, ZENECA-1839/0235, CASE-CCF-0757 |
Study First Received: | July 13, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00352105 History of Changes |
Health Authority: | United States: Federal Government |
stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx |
stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx |
Antimetabolites Immunologic Factors Laryngeal Carcinoma Squamous Cell Carcinoma Protein Kinase Inhibitors Immunosuppressive Agents Carcinoma Hypopharyngeal Cancer |
Cisplatin Radiation-Sensitizing Agents Head and Neck Neoplasms Fluorouracil Epidermoid Carcinoma Carcinoma, Squamous Cell Gefitinib |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Cisplatin Radiation-Sensitizing Agents Head and Neck Neoplasms Fluorouracil Therapeutic Uses Gefitinib |