Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer

This study is currently recruiting patients.

Sponsored by

Theradex

Purpose

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 Type: Treatment

Official Title: Phase II Study of Paclitaxel in Patients with Recurrent or Refractory Head and Neck Cancer

Further Study 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

Ages Eligible for Study:  18 Years  and above 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

Location and Contact Information

California

California Cancer Center, Fresno,    California,   93720,   United States; Recruiting

Michael Moffett       559-447-4050   

California

Loma Linda University Medical Center, Loma Linda,   California,   92354,   United States; Recruiting

David R. Bryson       909-824-4910   

Florida

Memorial Regional Cancer Center at Memorial Regional Hospital, Hollywood,   Florida,   33021,    United States; Recruiting

Frederick N. Wittlin       954-986-6363   

Florida

Sylvester Cancer Center, University of Miami, Miami,   Florida,   33136,   United States; Recruiting

Niramol Savaraj       305-243-4387   

Georgia

Savannah Hematology Oncology Associates, Savannah,   Georgia,   31405,   United States; Recruiting

Harvey C. Lebos       912-354-6187   

Illinois

Decatur Memorial Hospital Cancer Care Institute, Decatur,   Illinois,   62526,   United States; Recruiting

James L. Wade, III       217-876-6600   

Louisiana

Mary Bird Perkins Cancer Center, Baton Rouge,   Louisiana,   70809,   United States; Recruiting

David S. Hanson       225-767-1311   

Maine

Maine Center for Cancer Medicine and Blood Disorders, Scarborough,   Maine,   04074,   United States; Recruiting

Thomas J. Ervin       207-885-7600   

Maryland

Johns Hopkins Oncology Center, Baltimore,   Maryland,   21287,   United States; Recruiting

Arlene A. Forastiere       410-955-9818   

Missouri

Kansas City Internal Medicine, Kansas City,   Missouri,   64132,   United States; Recruiting

Larry J. Geier       816-363-4100   

New York

Lourdes Hospital, Binghamton,    New York,   13905,   United States; Recruiting

Jonathan D. Kloss       607-798-5307   

New York

Saint Vincent's Hospital and Medical Center - NY, New York,   New York,   10011,   United States; Recruiting

John Cho       212-604-7221   

North Carolina

Presbyterian Healthcare, Charlotte,    North Carolina,   28233-3549,   United States; Recruiting

James F. Boyd       704-384-8200   

Ohio

Akron City Hospital, Akron,    Ohio,   44309,   United States; Recruiting

Joseph M. Koenig       330-375-4495   

Ohio

Medical Oncology Hematology Associates, Inc., Dayton,   Ohio,   45409,   United States; Recruiting

Basel Yanes       937-223-2183   

Pennsylvania

Reading Hospital and Medical Center, Reading,   Pennsylvania,   19612-6052,   United States; Recruiting

Charles J. Lusch       610-374-4404   

Texas

Cancer Care Institute of South Texas, San Antonio,   Texas,   78229,   United States; Recruiting

Roger M. Lyons       210-595-5324   

Texas

Joe Arrington Cancer Research and Treatment Center, Lubbock,   Texas,   79410-1894,   United States; Recruiting

Charles E. Geyer, Jr.       806-725-7934   

Virginia

Danville Hematology and Oncology, Inc., Danville,   Virginia,   24541,   United States; Recruiting

Timothy W. Brotherton       804-793-0044   

Wisconsin

Medical College of Wisconsin, Milwaukee,   Wisconsin,   53226,   United States; Recruiting

Paul S. Ritch       414-805-4604   

Study chairs or principal investigators

Arlene A. Forastiere,  Study Chair

Theradex   

More Information

Study ID Numbers  199/13487;   THERADEX-B97-5250; NCI-V98-1415; BMS-TAX/MEN.05

NLM Identifier  NCT00003327

Date study started September 23, 1997

Last Updated  August 1, 1998

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