- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003327
Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer
A Phase II Trial of Paclitaxel (TAXOL) Administered as a Weekly One Hour Infusion in Previously Treated Patients With Advanced Head and Neck Cancer
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.
Study Overview
Detailed Description
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.
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Fresno, California, United States, 93720
- California Cancer Center
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Loma Linda, California, United States, 92354
- Loma Linda University Medical Center
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Florida
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Hollywood, Florida, United States, 33021
- Memorial Regional Cancer Center at Memorial Regional Hospital
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Miami, Florida, United States, 33136
- Sylvester Cancer Center, University of Miami
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Georgia
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Savannah, Georgia, United States, 31405
- Savannah Hematology Oncology Associates
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Illinois
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Decatur, Illinois, United States, 62526
- Decatur Memorial Hospital Cancer Care Institute
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Mary Bird Perkins Cancer Center
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Maine
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Scarborough, Maine, United States, 04074
- Maine Center for Cancer Medicine and Blood Disorders
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Maryland
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Baltimore, Maryland, United States, 21231-2410
- Johns Hopkins Oncology Center
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Missouri
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Kansas City, Missouri, United States, 64132
- Kansas City Internal Medicine
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New York
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Binghamton, New York, United States, 13905
- Lourdes Regional Cancer Center
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New York, New York, United States, 10011
- Saint Vincent Catholic Medical Center of New York
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North Carolina
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Charlotte, North Carolina, United States, 28233-3549
- Presbyterian Healthcare
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Ohio
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Akron, Ohio, United States, 44309
- Akron City Hospital
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Dayton, Ohio, United States, 45409
- Medical Oncology Hematology Associates, Inc.
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Pennsylvania
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Reading, Pennsylvania, United States, 19612-6052
- Reading Hospital and Medical Center
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Texas
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Lubbock, Texas, United States, 79410-1894
- Joe Arrington Cancer Research and Treatment Center
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San Antonio, Texas, United States, 78229
- Cancer Care Institute of South Texas
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Virginia
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Danville, Virginia, United States, 24541
- Danville Hematology and Oncology, Inc.
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent hypopharyngeal cancer
- stage IV hypopharyngeal cancer
- recurrent laryngeal cancer
- stage IV laryngeal cancer
- recurrent lip and oral cavity cancer
- stage IV lip and oral cavity cancer
- recurrent nasopharyngeal cancer
- stage IV nasopharyngeal cancer
- recurrent oropharyngeal cancer
- stage IV oropharyngeal cancer
- recurrent paranasal sinus and nasal cavity cancer
- stage IV paranasal sinus and nasal cavity cancer
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000066279
- THERADEX-B97-5250
- BMS-TAX/MEN.05
- NCI-V98-1415
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Cancer
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Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
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Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
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National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
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Radboud University Medical CenterUnknown
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Centre Oscar LambretUnknownEpidermoid Head and Neck CancerFrance
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