Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Recurrent or Refractory Cervical Cancer
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Trial Identification
Brief Title: Combination Chemotherapy in Treating Patients With Recurrent or Refractory Cervical Cancer
Official Title: A LIMITED ACCESS PHASE II TRIAL OF CISPLATIN AND NAVELBINE (VINORELBINE) IN ADVANCED AND RECURRENT SQUAMOUS CELL CARCINOMA OF THE CERVIX
Study ID: NCT00002813
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Chao Family Comprehensive Cancer Center, Orange, California, United States
MBCCOP - Hawaii, Honolulu, Hawaii, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States
Cancer Center of Albany Medical Center, Albany, New York, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Brookview Research, Inc., Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Mitchell Morris, MD
Affiliation: M.D. Anderson Cancer Center
Role: STUDY_CHAIR
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