A LIMITED ACCESS PHASE II TRIAL OF CISPLATIN AND NAVELBINE (VINORELBINE) IN ADVANCED AND RECURRENT SQUAMOUS CELL CARCINOMA OF THE CERVIX
OBJECTIVES: I. Determine the activity of cisplatin and vinorelbine in terms of response
rate, duration of response, time to treatment failure, and survival in patients with
advanced, persistent, or recurrent squamous cell carcinoma of the cervix.
OUTLINE: This is a multicenter study. Patients receive vinorelbine IV over 6-10 minutes on
days 1, 8, 15, and 22 and cisplatin IV over 4 hours beginning after completion of
vinorelbine infusion on day 1. Courses repeat every 4 weeks in the absence of disease
progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within
approximately 20 months.
Primary Purpose: Treatment
Mitchell Morris, MD
M.D. Anderson Cancer Center
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Chao Family Comprehensive Cancer Center||Orange, California 92868|
|MBCCOP - Hawaii||Honolulu, Hawaii 96813|
|Johns Hopkins Oncology Center||Baltimore, Maryland 21287|
|CCOP - Ann Arbor Regional||Ann Arbor, Michigan 48106|
|Cancer Center of Albany Medical Center||Albany, New York 12208|
|Comprehensive Cancer Center of Wake Forest University Baptist Medical Center||Winston-Salem, North Carolina 27157-1082|
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|Brookview Research, Inc.||Nashville, Tennessee 37203|