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Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer Clinical research trials and Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer healthcare trials happen in a lot of of localities 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 measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer. Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer  Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer
Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer
For Condition: Oral Cancer,Nose Cancer
Status: No longer recruiting
Sponsor(s): Theradex ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or refractory head and neck cancer.
Details: OBJECTIVES: I. Determine the objective response rate of paclitaxel as salvage therapy in patients with recurrent or refractory head and neck cancer. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival and quality of life in these patients. PROTOCOL OUTLINE: This is an open label, multicenter, nonrandomized study. Patients receive intravenous paclitaxel over 1 hour weekly. Each course consists of four weeks. Patients receive treatment until disease progression or unacceptable toxic effects are observed. Patients are followed every 2 months for the first year, then every 4 months until completion of treatment, and then every 3 months until death. Patients complete a quality of life questionnaire prior to each of the first 6 courses, then every 2 courses thereafter. PROJECTED ACCRUAL: A total of 60 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-- - Histologically proven recurrent or refractory head and neck cancer - Measurable or evaluable disease - At least one prior chemotherapy regimen for recurrent or metastatic disease --Prior/Concurrent Therapy-- - Biologic therapy: At least 3 weeks since prior immunotherapy; No concurrent immunotherapy - Chemotherapy: See Disease Characteristics; At least 5 weeks since prior nitrosoureas, melphalan, or mitomycin; At least 3 weeks since other prior chemotherapy; Prior taxane therapy allowed only if administered on a 3 week or greater schedule; No concurrent chemotherapy - Endocrine therapy: At least 3 weeks since prior hormonal therapy; Concurrent megestrol (Megace) allowed; No other concurrent hormonal therapy - Radiotherapy: At least 3 weeks since prior radiotherapy; No prior radiotherapy to greater than 30% of bone marrow; No concurrent radiotherapy - Surgery: At least 3 weeks since major surgery - Other: At least 1 week since prior parenteral antibiotics --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 3 months - Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 2 mg/dL; AST or ALT no greater than 2 times upper limit of normal (ULN) - Renal: Creatinine no greater than 2 times ULN; Calcium within normal limits Cardiovascular: No New York Heart Association class III-IV heart disease; No myocardial infarction within 6 months; No congestive heart failure; No unstable angina; No clinically significant pericardial effusions or arrhythmias - Neurologic: No peripheral neuropathy greater than grade 1 Other: Not pregnant or nursing; Fertile patients must use effective contraceptive method; Negative pregnancy test; No active infection or serious underlying medical condition; No history of hypersensitivity to drugs containing Cremophor (teniposide, cyclosporine, or vitamin K); No prior invasive malignancies within the past 2 years, except: Curatively treated basal or squamous cell carcinoma of the skin; Carcinoma in situ of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ArleneForastiere, Study Chair, Theradex
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231-2410
United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894
United States
California Cancer Center
Fresno, California, 93720
United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, 04074
United States
Savannah Hematology Oncology Associates
Savannah, Georgia, 31405
United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Cancer Care Institute of South Texas
San Antonio, Texas, 78229
United States
Memorial Regional Cancer Center at Memorial Regional Hospital
Hollywood, Florida, 33021
United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
United States
Lourdes Regional Cancer Center
Binghamton, New York, 13905
United States
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
United States
Loma Linda University Medical Center
Loma Linda, California, 92354
United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
Medical Oncology Hematology Associates, Inc.
Dayton, Ohio, 45409
United States
Akron City Hospital
Akron, Ohio, 44309
United States
Presbyterian Healthcare
Charlotte, North Carolina, 28233-3549
United States
Danville Hematology and Oncology, Inc.
Danville, Virginia, 24541
United States
Saint Vincent Catholic Medical Center of New York
New York City, New York, 10011
United States
Kansas City Internal Medicine
Kansas City, Missouri, 64132
United States
Additional Information:
Study ID Numbers: CDR0000066279; THERADEX-B97-5250,NCI-V98-1415,BMS-TAX/MEN.05
Study Start Date: September 1997
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003327
Other Oral Cancer Studies:
1. ZD1839 in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck
2. Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
3. Cetuximab Plus Cisplatin in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck That Has Not Responded to Cisplatin Chemotherapy
4. Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer
5. Combination Chemotherapy Plus Radiation Therapy in Treating Patients with Head and Neck Cancer
Related Studies:
Other Oral Cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer
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