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Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer Clinical research trials and Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer. Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer  Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
For Condition: Head and Neck Cancer
Status: Recruiting
Sponsor(s): Huntsman Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor cells by blocking an enzyme necessary for cell growth. PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent and/or metastatic head and neck cancer.
Details: OBJECTIVES: - Determine the disease control rate, in terms of complete response, partial response, and stable disease for at least 4 months, in patients with recurrent and/or metastatic squamous cell cancer of the head and neck treated with gefitinib. - Determine the effect of this drug on epidermal growth factor receptor phosphorylation and expression of selected genes in these patients. - Determine the toxic effects of this drug in these patients. OUTLINE: Patients are stratified as delineated in the Disease Characteristics. Patients receive oral gefitinib daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 50-60 patients (25-30 per stratum) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed primary squamous cell cancer of the head and neck that is incurable by surgery or radiotherapy - Failed surgery and/or radiotherapy and received no prior systemic chemotherapy for recurrent disease OR - Recurrent disease at least 6 months after prior multimodal primary therapy including neoadjuvant or concurrent chemotherapy OR - Metastatic disease at initial diagnosis and received no prior chemotherapy - No more than 1 prior chemotherapy regimen for recurrent disease OR - Recurrent disease within 6 months after prior primary therapy that included chemotherapy - Measurable disease - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - Clear clinical evidence of progression or biopsy-proven residual cancer required if only site of measurable disease is in a previously irradiated field - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - More than 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin normal (no greater than 1.5 times upper limit of normal [ULN] if liver metastases present) - AST/ALT no greater than 2.5 times ULN Renal: - Creatinine no greater than 1.5 times ULN OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other: - No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No other uncontrolled concurrent illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - No prior allergic reactions attributed to compounds of similar chemical or biologic composition to gefitinib - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior therapy with agents that target epidermal growth factor receptors Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: - No concurrent tamoxifen Radiotherapy: - See Disease Characteristics - Prior radiotherapy as primary or secondary treatment allowed - At least 4 weeks since prior radiotherapy and recovered Surgery: - See Disease Characteristics - Prior surgery as primary or secondary treatment allowed - At least 4 weeks since prior major surgery Other: - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV - No concurrent 3A4 inhibitors (e.g., ketoconazole, erythromycin, verapamil) - No concurrent drugs with known corneal toxicity (e.g., chlorpromazine, amiodarone, chloroquine)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardWheeler, Study Chair, Huntsman Cancer Institute
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112
United States
Recruiting Richard Wheeler 801-585-0601
Additional Information:
Study ID Numbers: CDR0000068890; NCI-1701,UUMC-8429-01
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024089
Other Head And Neck Cancer Studies:
1. Boronophenylalanine-Fructose Complex (BPA-F) and/or Sodium Borocaptate (BSH) Followed By Surgery in Treating Patients With Thyroid Cancer, Head and Neck Cancer, or Liver Metastases
2. Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
3. Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
4. Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
5. OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer
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Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
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