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A Phase II Trial of Paclitaxel (TAXOL) Administered as a Weekly One Hour Infusion in Previously Treated Patients With Advanced Head and Neck Cancer

Phase 2
18 Years
Open (Enrolling)
Head and Neck Cancer

Thank you

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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Arlene A. Forastiere, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Federal Government

Study ID:




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



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