A Phase II Trial of Paclitaxel (TAXOL) Administered as a Weekly One Hour Infusion in Previously Treated Patients With Advanced Head and Neck Cancer
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
A Phase II Trial of Paclitaxel (TAXOL) Administered as a Weekly One Hour Infusion in Previously Treated Patients With Advanced Head and Neck Cancer
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.
Inclusion 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
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Arlene A. Forastiere, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000066279
NCT ID:
NCT00003327
Start Date:
September 1997
Completion Date:
Related Keywords:
- Head and Neck Cancer
- stage IV nasopharyngeal cancer
- recurrent nasopharyngeal cancer
- stage IV lip and oral cavity cancer
- recurrent lip and oral cavity cancer
- stage IV hypopharyngeal cancer
- recurrent hypopharyngeal cancer
- stage IV laryngeal cancer
- recurrent laryngeal cancer
- stage IV paranasal sinus and nasal cavity cancer
- recurrent paranasal sinus and nasal cavity cancer
- stage IV oropharyngeal cancer
- recurrent oropharyngeal cancer
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Akron City Hospital | Akron, Ohio 44304 |
| Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
| Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
| Presbyterian Healthcare | Charlotte, North Carolina 28233-3549 |
| Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
| California Cancer Center | Fresno, California 93720 |
| Loma Linda University Medical Center | Loma Linda, California 92354 |
| Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
| Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
| Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
| Lourdes Regional Cancer Center | Binghamton, New York 13905 |
| Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
| Savannah Hematology Oncology Associates | Savannah, Georgia 31405 |
| Memorial Regional Cancer Center at Memorial Regional Hospital | Hollywood, Florida 33021 |
| Maine Center for Cancer Medicine and Blood Disorders | Scarborough, Maine 04074 |
| Kansas City Internal Medicine | Kansas City, Missouri 64132 |
| Saint Vincent Catholic Medical Center of New York | New York, New York 10011 |
| Medical Oncology Hematology Associates, Inc. | Dayton, Ohio 45409 |
| Cancer Care Institute of South Texas | San Antonio, Texas 78229 |
| Danville Hematology and Oncology, Inc. | Danville, Virginia 24541 |
