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Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer Clinical research trials and Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer. Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer  Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer
For Condition: Oral Cancer,Throat Cancer
Status: No longer recruiting
Sponsor(s): Massachusetts General Hospital ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel and radiation therapy plus chemoprotection with amifostine in treating patients with stage III or stage IV head and neck cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of paclitaxel with amifostine and radiotherapy in patients with stage III or IV head and neck cancer. II. Determine the toxic effects and complications of this regimen in terms of mucositis reduction in these patients. III. Determine the complete response rate and progression-free survival of patients treated with this regimen. IV. Determine whether amifostine modulates the plasma pharmacokinetics of paclitaxel in these patients. PROTOCOL OUTLINE: This is a dose-escalation study of paclitaxel with and without amifostine. Patients receive paclitaxel IV on days 1, 8, 15, 29, 36, and 43 for a total of 3-6 doses. Patients also undergo radiotherapy twice daily for 6 weeks, except for days when paclitaxel is given. Cohorts of 2-5 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2-3 patients experience dose-limiting toxicity. An additional 10 patients are treated at the MTD. After determination of the MTD for paclitaxel, subsequent patients also receive amifostine IV over 15 minutes on days 1, 8, 29, and 36 and radiotherapy on days 2-5 and 30-33. Determination of the MTD for this drug combination is carried out as with paclitaxel alone. At 4 to 8 weeks after the last treatment of radiotherapy, patients undergo CT scanning to determine response. Patients with residual masses undergo neck dissection. Patients with complete or partial response at the primary site are followed without surgery. Patients are followed every 6 months. PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed stage III or IV squamous cell head and neck cancer - T3-4, N0-3, M0 --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent beta-adrenergic blocking agents --Patient Characteristics-- Age: 18 and over Performance Status: ECOG 0-2 Life Expectancy: Not specified Hematopoietic: - WBC at least 2,000/mm3 - Platelet count at least 50,000/mm3 Hepatic: - Bilirubin no greater than 3.0 mg/dL - SGOT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 3.0 mg/dL Other: Not pregnant or nursing
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PhilipAmrein, Study Chair, Massachusetts General Hospital
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Additional Information:
Study ID Numbers: CDR0000066028; MGH-M7-20,NCI-V98-1384,ALZA-97-024-ii
Study Start Date: January 1998
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003193
Other Oral Cancer Studies:
1. Combination Chemotherapy Plus Radiation Therapy in Treating Patients with Head and Neck Cancer
2. Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer
3. Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer
4. Radiation Therapy With or Without Epoetin alfa in Treating Patients With Head and Neck Cancer
5. Chemotherapy in Treating Patients With Solid Tumors
Related Studies:
Other Oral Cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer
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