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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00083057 |
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving gefitinib and paclitaxel together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gefitinib and paclitaxel when given together with radiation therapy in treating patients with advanced or recurrent squamous cell carcinoma (cancer) of the head and neck.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: gefitinib Drug: paclitaxel Radiation: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Pilot Phase I Dose Escalation Study Of The EGFR Tyrosine Kinase Inhibitor Gefitinib (Iressa) Combined With Paclitaxel (Taxol) And External Beam Radiation Therapy In Patients With Advanced Squamous Cell Carcinoma Of The Head And Neck (SCCHN) |
Estimated Enrollment: | 30 |
Study Start Date: | May 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot, dose-escalation study of gefitinib and paclitaxel.
Patients receive oral gefitinib once daily beginning on day 1 and continuing until completion of radiotherapy.
Patients receive paclitaxel IV over 1 hour on days 8, 15, 22, 29, 36, and 43 and undergo radiotherapy once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, 43-47, 50-54, and 57-61. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gefitinib and paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A cohort of 6 additional patients receive treatment at the MTD.
Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 3 months for 3 years.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell (epidermoid) carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, or maxillary sinus
Distant metastases allowed provided both of the following are true:
Meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
No clinically active interstitial lung disease
Other
No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent administration of any of the following:
United States, Maryland | |
NCI - Metabolism Branch;MET | |
Bethesda, Maryland, United States, 20892-1547 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Carter Van Waes, MD, PhD | National Institute on Deafness and Other Communication Disorders (NIDCD) |
Principal Investigator: | John C. Morris, MD | NCI - Metabolism Branch;MET |
Study ID Numbers: | CDR0000362055, NCI-04-C-0141 |
Study First Received: | May 14, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00083057 History of Changes |
Health Authority: | United States: Food and Drug Administration |
stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx |
recurrent squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the nasopharynx stage III squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx |
Nasopharyngeal Carcinoma Laryngeal Carcinoma Carcinoma, Squamous Cell of Head and Neck Tyrosine Antimitotic Agents Squamous Cell Carcinoma Protein Kinase Inhibitors Recurrence Carcinoma Hypopharyngeal Cancer |
Paclitaxel Head and Neck Neoplasms Tubulin Modulators Epidermoid Carcinoma Neoplasms, Squamous Cell Carcinoma, Squamous Cell Antineoplastic Agents, Phytogenic Gefitinib Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Protein Kinase Inhibitors Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Paclitaxel Therapeutic Uses Head and Neck Neoplasms Tubulin Modulators Neoplasms, Squamous Cell Carcinoma, Squamous Cell Antineoplastic Agents, Phytogenic Gefitinib Neoplasms, Glandular and Epithelial |