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Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Stage III or Stage IV Head and Neck Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Stage III or Stage IV Head and Neck Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Stage III or Stage IV Head and Neck Cancer Clinical research trials and Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Stage III or Stage IV Head and Neck Cancer health trials occur in a lot of of places throughout 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 typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Stage III or Stage IV Head and Neck Cancer. Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Stage III or Stage IV Head and Neck Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Stage III or Stage IV Head and Neck Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Stage III or Stage IV Head and Neck Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Stage III or Stage IV Head and Neck Cancer  Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Stage III or Stage IV Head and Neck Cancer
Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Stage III or Stage IV Head and Neck Cancer
For Condition: recurrent squamous cell carcinoma of the oropharynx,recurrent squamous cell carcinoma of the larynx,stage 4 squamous cell carcinoma of the hypopharynx,stage 3 squamous cell carcinoma of the lip and oral cavity,recurrent squamous cell carcinoma of the hypopharynx,recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity,stage 3 squamous cell carcinoma of the oropharynx,stage 3 squamous cell carcinoma of the paranasal sinus and nasal cavity,stage 4 squamous cell carcinoma of the lip and oral cavity,stage 3 squamous cell carcinoma of the hypopharynx,stage 4 squamous cell carcinoma of the larynx,stage 3 squamous cell carcinoma of the larynx,stage 4 squamous cell carcinoma of the oropharynx,Quality of Life,recurrent squamous cell carcinoma of the lip and oral cavity,stage 4 squamous cell carcinoma of the paranasal sinus and nasal cavity
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: RATIONALE: Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use 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 chemotherapy with monoclonal antibody therapy and radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining cetuximab, cisplatin, and radiation therapy in treating patients who have advanced stage III or stage IV head and neck cancer.
Details: OBJECTIVES: I. Determine the response rate in patients with newly diagnosed or recurrent, advanced stage III or IV squamous cell carcinoma of the head and neck treated with 6 infusions of cetuximab at loading/maintenance doses in combination with 2 infusions of cisplatin concurrent with standard/delayed accelerated hyperfractionated radiotherapy followed by 4 weeks of single agent cetuximab. II. Assess the safety profile of this treatment regimen in this patient population. III. Evaluate time to disease progression and survival in these patients treated with this regimen. IV. Assess the impact of this treatment regimen on the quality of life of these patients. PROTOCOL OUTLINE: Patients receive a loading dose of cetuximab IV over 120 minutes on week 1 followed by 5 weekly maintenance doses over 60 minutes on weeks 2-6. Patients receive cisplatin IV over 30 minutes on weeks 1 and 4 beginning 1 hour after completion of cetuximab infusion. Radiotherapy is administered once daily during weeks 1-4 and twice daily during weeks 5 and 6. Following the initial 6 weeks of treatment, patients receive additional cetuximab IV over 30 minutes weekly on weeks 7-10. Quality of life is assessed at baseline, within 4 weeks after completion of all treatment, and at 3-4 months. Patients are followed at 4-6 weeks, 12-16 weeks, every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 2 years. PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Newly diagnosed or recurrent, advanced stage III or IV squamous cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or paranasal sinus/nasal cavity; M0; No nasopharyngeal cancer - Measurable or evaluable disease --Prior/Concurrent Therapy-- - Biologic therapy: No prior murine monoclonal antibody therapy; No prior cetuximab; No prior immunotherapy - Chemotherapy: At least 3 years since prior chemotherapy; No other concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy to the head or neck region; No other concurrent radiotherapy - Surgery: At least 60 days since prior surgery; Diagnostic biopsy allowed --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100%; ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Granulocyte count at least 1,500/mm3; Hemoglobin at least 9 g/dL; Platelet count at least 100,000/mm3 Hepatic: Alkaline phosphatase no greater than 2.5 times upper limit of normal; (ULN) AST no greater than 2.5 times ULN; Bilirubin no greater than 1.5 times ULN - Renal: Creatinine no greater than 1 times ULN; Creatinine clearance at least 60 mL/min; Calcium no greater than 11.5 mg/dL - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelZelefsky, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000067817; MSKCC-99095,NCI-G00-1785
Study Start Date: December 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005814
Other Stage 3 Squamous Cell Carcinoma Of The Oropharynx Studies:
1. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
2. Radiation Therapy and Cisplatin in Treating Patients With Advanced Head and Neck Cancer
3. Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer
4. Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
5. Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer
Related Studies:
Other stage 3 squamous cell carcinoma of the oropharynx Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Stage III or Stage IV Head and Neck Cancer
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