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Study 14 of 4397 for search of: | United States, Georgia |
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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00088907 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining docetaxel with gefitinib may kill more tumor cells. It is not yet known whether docetaxel is more effective with or without gefitinib in treating head and neck cancer.
PURPOSE: This randomized phase III trial is studying docetaxel and gefitinib to see how well they work compared to docetaxel alone in treating patients with metastatic or locally recurrent head and neck cancer.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: docetaxel Drug: gefitinib Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | Phase III Randomized, Placebo Controlled, Trial Of Docetaxel Versus Docetaxel Plus ZD1839 (Iressa, Gefitinib, NSC 715055) In Performance Status 2 Or Previously Treated Patients With Recurrent Or Metastatic Head And Neck Cancer |
Estimated Enrollment: | 330 |
Study Start Date: | August 2004 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive docetaxel IV over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.
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Drug: docetaxel
Given IV over 30-60 minutes
Drug: placebo
Given orally
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Arm II: Experimental
Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.
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Drug: docetaxel
Given IV over 30-60 minutes
Drug: gefitinib
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to treatment with prior chemotherapy (pretreated vs untreated), ECOG performance status (0 vs 1 vs 2), weight loss within the past 6 months (< 5% vs ≥ 5%), and prior cetuximab treatment (yes or no). Patients are randomized to 1 of 2 treatment arms.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
Quality of life is assessed at baseline, on days 15 and 28 of course 1, on day 28 of all subsequent courses, and at 2-4 weeks after completion of study treatment.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 330 patients (165 per treatment arm) will be accrued for this study within 31.5 months.
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 carcinoma of the head and neck
Meets 1 of the following criteria:
Measurable or non-measurable disease
Disease within a previously irradiated field is considered measurable provided there is unequivocal disease progression or biopsy-proven residual carcinoma after radiotherapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Alkaline phosphatase AND AST or ALT meeting criteria for 1 of the following:
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior cetuximab
Chemotherapy
Endocrine therapy
No concurrent antitumor hormonal therapy
Radiotherapy
Surgery
Other
No other prior systemic epidermal growth factor receptor inhibitors, including any of the following:
No concurrent CYP3A4 inducers, including any of the following:
Study Chair: | Athanassios Argiris, MD | UPMC Cancer Centers |
Investigator: | Jill Gilbert, MD | MBCCOP - LSU Health Sciences Center |
Study ID Numbers: | CDR0000377545, ECOG-E1302 |
Study First Received: | August 4, 2004 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00088907 |
Health Authority: | United States: Food and Drug Administration |
recurrent squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage III squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent metastatic squamous neck cancer with occult primary untreated metastatic squamous neck cancer with occult primary recurrent salivary gland cancer salivary gland squamous cell carcinoma stage III salivary gland cancer stage IV salivary gland cancer |
recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx stage IV 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 |
Squamous cell carcinoma Recurrence Carcinoma Epidermoid carcinoma Docetaxel Nasopharyngeal carcinoma Head and Neck Neoplasms |
Metastatic squamous neck cancer with occult primary Carcinoma, squamous cell Laryngeal carcinoma Hypopharyngeal cancer Carcinoma, Squamous Cell Gefitinib Salivary Gland Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |