Combination Chemotherapy in Treating Patients With Recurrent or Refractory Cervical Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with cisplatin and vinorelbine in treating patients with refractory or recurrent squamous cell cervical cancer that has not responded to local therapy.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A LIMITED ACCESS PHASE II TRIAL OF CISPLATIN AND NAVELBINE (VINORELBINE) IN ADVANCED AND RECURRENT SQUAMOUS CELL CARCINOMA OF THE CERVIX|
|Study Start Date:||August 1997|
|Primary Completion Date:||October 2004 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002813
|United States, California|
|Chao Family Comprehensive Cancer Center|
|Orange, California, United States, 92868|
|United States, Hawaii|
|MBCCOP - Hawaii|
|Honolulu, Hawaii, United States, 96813|
|United States, Maryland|
|Johns Hopkins Oncology Center|
|Baltimore, Maryland, United States, 21231|
|United States, Michigan|
|CCOP - Ann Arbor Regional|
|Ann Arbor, Michigan, United States, 48106|
|United States, New York|
|Cancer Center of Albany Medical Center|
|Albany, New York, United States, 12208|
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157-1082|
|United States, South Carolina|
|CCOP - Upstate Carolina|
|Spartanburg, South Carolina, United States, 29303|
|United States, Tennessee|
|Brookview Research, Inc.|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Mitchell Morris, MD||M.D. Anderson Cancer Center|