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Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Head and Neck Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Head and Neck conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Head and Neck Clinical research trials and Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Head and Neck health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Head and Neck. Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Head and Neck Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Head and Neck clinical trial. Participants oftentimes recieve the most expert healthcare available for their Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Head and Neck condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Head and Neck  Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Head and Neck
Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Head and Neck
For Condition: paranasal sinus and nasal cavity cancer,lip and oral cavity cancer,Oropharyngeal Cancer,Hypopharyngeal Cancer,Laryngeal Cancer
Status: Not yet recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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. Combining gefitinib and paclitaxel with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining gefitinib and paclitaxel with radiation therapy in treating patients who have advanced squamous cell carcinoma (cancer) of the head and neck.
Details: OBJECTIVES: Primary - Determine the dose-limiting toxicity, toxicity profile, and maximum tolerated dose (MTD) of gefitinib and paclitaxel administered with radiotherapy in patients with advanced squamous cell carcinoma of the head and neck. Secondary - Determine the efficacy of this regimen in patients treated at the MTD. OUTLINE: This is a pilot, dose-escalation study of gefitinib and paclitaxel. Patients receive oral gefitinib once daily on days 1-112 and paclitaxel IV over 1 hour on days 8, 15, 22, 29, 36, and 43. In addition, patients 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed squamous cell (epidermoid) carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, or maxillary sinus - Stage III or IV disease - Distant metastases allowed provided both of the following are true: - Metastases are confined to the head and neck region - Metastases are encompassable in a radiotherapy field with curative intent - Meets 1 of the following criteria: - Unresectable disease - Patient prefers chemoradiotherapy over surgery - Measurable disease - No brain metastases and/or carcinomatous meningitis PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - WBC 3,000/mm^3 - Hemoglobin > 10 g/dL - Platelet count > 100,000/mm^3 - Absolute neutrophil count 1,500/mm^3 Hepatic - Bilirubin < 2.0 times upper limit of normal (ULN) - AST/ALT 2.5 times ULN Renal - Creatinine < 1.5 times ULN OR - Creatinine clearance 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Pulmonary - No clinically active interstitial lung disease - Chronic, stable, asymptomatic radiographic changes allowed Other - No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs or Cremophor^® EL - No AIDS or primary immunodeficiencies - No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma - of the cervix - Probability of recurrence of the prior malignancy < 5% - No other concurrent uncontrolled illness - No ongoing or active serious infection - No psychiatric illness or situation that would preclude study compliance or giving informed consent - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for cancer - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior therapeutic radiotherapy to the head and neck region Surgery - At least 4 weeks since prior major surgery and recovered Other - No prior gefitinib or other epidermal growth factor receptor inhibitors - More than 4 weeks since prior non-approved or investigational agents - No concurrent administration of any of the following: - Phenytoin - Carbamazepine - Barbiturates - Rifampin - Hypericum perforatum (St. John's wort) - Oxcarbazepine - Rifapentine - Amifostine - Modafinil - Other CYP3A4 enzyme inducers - Other anticancer agents or investigational drugs - Combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BarbaraConley, , National Cancer Institute (NCI)
Additional Information:
Study ID Numbers: CDR0000362055; NCI-04-C-0141,NCI-5926
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083057
Other Paranasal Sinus And Nasal Cavity Cancer Studies:
1. Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
2. Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
3. Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer
4. Docetaxel in Treating Patients With Solid Tumors and Abnormal Liver Function
5. Gene Therapy in Treating Patients With Advanced Head and Neck Cancer
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Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Head and Neck
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