Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer
NCT ID: NCT00003327
Last Updated: 2008-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
1997-09-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or refractory head and neck cancer.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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paclitaxel
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Theradex
INDUSTRY
Principal Investigators
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Arlene A. Forastiere, MD
Role: STUDY_CHAIR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations
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California Cancer Center
Fresno, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Memorial Regional Cancer Center at Memorial Regional Hospital
Hollywood, Florida, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
Savannah Hematology Oncology Associates
Savannah, Georgia, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
Kansas City Internal Medicine
Kansas City, Missouri, United States
Lourdes Regional Cancer Center
Binghamton, New York, United States
Saint Vincent Catholic Medical Center of New York
New York, New York, United States
Presbyterian Healthcare
Charlotte, North Carolina, United States
Akron City Hospital
Akron, Ohio, United States
Medical Oncology Hematology Associates, Inc.
Dayton, Ohio, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Cancer Care Institute of South Texas
San Antonio, Texas, United States
Danville Hematology and Oncology, Inc.
Danville, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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THERADEX-B97-5250
Identifier Type: -
Identifier Source: secondary_id
BMS-TAX/MEN.05
Identifier Type: -
Identifier Source: secondary_id
NCI-V98-1415
Identifier Type: -
Identifier Source: secondary_id
CDR0000066279
Identifier Type: -
Identifier Source: org_study_id