Spots Global Cancer Trial Database for Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer
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Trial Identification
Brief Title: Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer
Official Title: A Phase II Trial of Paclitaxel (TAXOL) Administered as a Weekly One Hour Infusion in Previously Treated Patients With Advanced Head and Neck Cancer
Study ID: NCT00003327
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Arlene A. Forastiere, MD
Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: STUDY_CHAIR
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