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Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer Clinical research trials and Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer medical trials take place in many of places 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 usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer. Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer clinical trial. Test subjects typically obtain the finest healthcare available for their Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer  Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
For Condition: lip and oral cavity cancer,Hypopharyngeal Cancer,Nasopharyngeal Cancer,Oropharyngeal Cancer,Laryngeal Cancer
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining erlotinib with docetaxel may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining erlotinib with docetaxel and radiation therapy in treating patients who have locally advanced head and neck cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of erlotinib when administered with docetaxel and radiotherapy in patients with locally advanced squamous cell cancer of the head and neck. - Determine the toxicity of this regimen in these patients. - Determine the pharmacokinetic profile of erlotinib alone and in combination with docetaxel in these patients. - Determine the overall and complete response rate in patients treated with this regimen. - Determine the overall, disease-free, and progression-free survival of patients treated with this regimen. OUTLINE: This is a dose-escalation study of erlotinib and docetaxel. Patients receive oral erlotinib alone daily on weeks 1 and 2. Patients then receive oral erlotinib daily beginning on day 1 and docetaxel IV over 1 hour on day 3 of weeks 3-9. Patients also undergo radiotherapy once daily 5 days a week on weeks 3-9. Patients continue erlotinib for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients who had N2 or greater cervical lymph node involvement at baseline or have residual neck adenopathy after chemoradiotherapy undergo neck dissection 6-8 weeks after completion of chemoradiotherapy. Erlotinib is held for 1 week before planned surgery and until healing is complete. Cohorts of 3-6 patients receive escalating doses of erlotinib and docetaxel 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. Patients are followed every 16 weeks for 1 year after completion of erlotinib, every 24 weeks for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed squamous cell carcinoma of the head and neck - Stage III or IV (locally advanced disease) - No distant metastatic disease - Measurable disease - No salivary gland or paranasal sinus squamous cell carcinoma - No known brain metastases or direct cerebral invasion by tumor - Intracranial extension without cerebral involvement may be allowed PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - Bilirubin normal - AST/ALT no greater than 2 times upper limit of normal - Prothrombin time normal Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - No clinically significant heart disease - No New York Heart Association class III or IV heart disease - No significant arrhythmias requiring medication - No symptomatic coronary artery disease - No myocardial infarction within the past 6 months - No second- or third-degree heart block or bundle branch block - No symptomatic congestive heart failure - No unstable angina pectoris Other - No prior allergic reactions attributed to compounds of similar chemical or biological composition to erlotinib or docetaxel, including other drugs formulated with polysorbate 80 - No pre-existing peripheral neuropathy grade 2 or greater - No other concurrent uncontrolled illness that would preclude study participation - No ongoing or active infection - No psychiatric illness or social situation that would preclude study participation - No other malignancy within the past 5 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix - No patients who are considered poorly compliant - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent routine colony-stimulating factors Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy Surgery - Not specified Other - No prior investigational antitumor drugs - No other concurrent commercial or investigational anticancer agents or therapies
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScotRemick, Study Chair, University Hospitals of Cleveland
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15236
United States
Recruiting Dong Shin 412-235-1021
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Scot Remick 216-844-1196
Additional Information:
Study ID Numbers: CDR0000258046; CWRU-050212,CWRU-1301,NCI-5389
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049283
Other Lip And Oral Cavity Cancer Studies:
1. Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery
2. Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer
3. Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx
4. Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer
5. Radiation Therapy With or Without Epoetin alfa in Anemic Patients With Head and Neck Cancer
Related Studies:
Other lip and oral cavity cancer Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
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