Purpose
Paclitaxel in Treating
Patients With Advanced Head and Neck Cancer
This study is currently
recruiting patients.
Sponsored by
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
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 metastatic head and neck cancer.
Condition
|
Treatment
or Intervention |
Phase |
stage
IV squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal
cavity stage IV squamous cell carcinoma of the hypopharynx |
Drug: cimetidine
Drug: dexamethasone Drug: diphenhydramine hydrochloride Drug: filgrastim Drug: paclitaxel |
Phase II |
Study Type: Treatment
Official Title: Phase II Study of 96 Hour Paclitaxel Infusion in
Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Further Study Details: OBJECTIVES: I. Evaluate the response rate
and toxic effects of paclitaxel by 96 hour continuous infusion in chemotherapy naive and
chemotherapy exposed patients with recurrent or metastatic squamous cell carcinoma of the
head and neck. PROTOCOL OUTLINE: Patients receive paclitaxel as a 96 hour continuous
IV infusion. Courses repeat every 3 weeks for a maximum of 12 courses. Patients with
disease progression after 2 courses or with unacceptable toxicity at any time are removed
from study. PROJECTED ACCRUAL: An estimated 109 patients will be accrued over 4
years.
Eligibility
Ages Eligible for Study: 18 Years
and above Criteria
PROTOCOL ENTRY CRITERIA: --Disease
Characteristics-- Histologically proven squamous cell carcinoma of the head and neck
(including nasopharynx) that is considered incurable with surgery or radiation therapy
Bidimensionally measurable disease Patients whose only site of measurable disease is
within a previous radiation port must have documented progressive disease or biopsy-proven
recurrence after the completion of radiotherapy No uncontrolled CNS metastases
Chemotherapy naive patients must be offered Protocol E-1395, if appropriate, before being
considered for this study --Prior/Concurrent Therapy-- Biologic therapy: Prior
interleukin-2, interferons, and monoclonal antibodies allowed Recovered from prior therapy
Chemotherapy: Prior paclitaxel infusion no greater than 24 hours for recurrent or
metastatic disease required Endocrine therapy: Not specified Radiotherapy: Recovered from
prior radiotherapy Surgery: Recovered from any prior major surgery --Patient
Characteristics-- Age: 18 and over Performance status: ECOG 0 or 1 Hematopoietic: Absolute
neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin
no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine
clearance at least 60 mL/min Calcium normal No history of hypercalcemia Cardiovascular: No
history of ventricular arrhythmias or symptomatic bradyarrhythmia Other: No significant
detectable infection Not pregnant or nursing No other active malignancies Fertile patients
must use effective contraception
Location and Contact Information
South Africa
Pretoria Academic Hospital, Pretoria,
0001, South Africa; Recruiting
Carla I. Falkson
27-12-361-3082
California
Stanford University Medical
Center, Stanford, California, 94305-5408, United
States; Recruiting
Harlan A. Pinto
415-723-6454
California
Veterans Affairs Medical Center - Palo
Alto, Palo Alto, California, 94304, United
States; Recruiting
Harlan A. Pinto
415-723-6454
Florida
H. Lee Moffitt Cancer Center and Research
Institute, Tampa, Florida, 33612, United
States; Recruiting
Henry Wagner, Jr.
813-979-7282
Florida
Sylvester Cancer Center, University of
Miami, Miami, Florida, 33136, United
States; Recruiting
Stephen Richman
305-243-4909
Georgia
Emory University Hospital -
Atlanta, Atlanta, Georgia, 30322, United
States; Recruiting
William Costin Wood
404-778-3301
Georgia
Veterans Affairs Medical Center - Atlanta
(Decatur), Decatur, Georgia, 30033, United
States; Recruiting
Maria Jose Amarante Ribeiro
404-728-7680
Illinois
CCOP - Carle Cancer Center, Urbana,
Illinois, 61801, United States; Recruiting
Alan K. Hatfield
217-383-3010
Illinois
CCOP - Illinois Oncology Research
Association, Peoria, Illinois, 61602, United
States; Recruiting
John W. Kugler
309-671-5180
Illinois
Robert H. Lurie Comprehensive Cancer
Center, Northwestern University, Chicago, Illinois, 60611,
United States; Recruiting
Al Bowen Benson, III
312-695-6180
Illinois
Veterans Affairs Medical Center - Chicago
(Lakeside), Chicago, Illinois, 60611, United
States; Recruiting
Timothy M. Kuzel
312-908-5284
Massachusetts
New England Medical Center
Hospital, Boston, Massachusetts, 02111, United
States; Recruiting
John K. Erban, III
617-636-5147
Michigan
CCOP - Kalamazoo, Kalamazoo,
Michigan, 49007-3731, United States; Recruiting
Raymond S. Lord, III
616-373-7488
Minnesota
CCOP - Metro-Minnesota, Saint Louis
Park, Minnesota, 55416, United States; Recruiting
Patrick J. Flynn
612-863-8585
Nebraska
CCOP - Missouri Valley Cancer
Consortium, Omaha, Nebraska, 68131, United
States; Recruiting
James A. Mailliard
402-398-6064
New Jersey
Veterans Affairs Medical Center - East
Orange, East Orange, New Jersey, 07018-1095,
United States; Recruiting
Basil S. Kasimis
973-676-1000 ext 1544
New York
University of Rochester Cancer
Center, Rochester, New York, 14642, United
States; Recruiting
John M. Bennett
716-275-4915
North Dakota
CCOP - Merit Care Hospital, Fargo,
North Dakota, 58122, United States; Recruiting
Ralph Levitt
701-234-7592
Ohio
Ireland Cancer Center, Cleveland,
Ohio, 44106-5065, United States; Recruiting
Edward G. Mansour
216-778-4394
Pennsylvania
CCOP - Geisinger Clinical and Medical
Center, Danville, Pennsylvania, 17822-2001,
United States; Recruiting
Albert M. Bernath, Jr.
570-271-6413
Pennsylvania
CCOP - MainLine Health, Wynnewood,
Pennsylvania, 19096, United States; Recruiting
Paul Gilman
610-645-2494
Pennsylvania
Fox Chase Cancer Center, Philadelphia,
Pennsylvania, 19111, United States; Recruiting
Corey Jay Langer
215-728-2985
Wisconsin
Medical College of
Wisconsin, Milwaukee, Wisconsin, 53226, United
States; Recruiting
Tom Anderson
414-805-4600
Wisconsin
Veterans Affairs Medical Center - Milwaukee
(Zablocki), Milwaukee, Wisconsin, 53295, United
States; Recruiting
Joseph A. Libnoch
414-257-5636
Study chairs or principal investigators
Corey Jay Langer, Study Chair
Eastern Cooperative Oncology Group
More Information
Study ID Numbers 199/12363;
E-3395
NLM Identifier NCT00002922
Date study started January 7, 1997
Last Updated June 1, 2000