Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix
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 bryostatin-1 plus cisplatin in treating patients who have recurrent or advanced cancer of the cervix.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Clinical Trial of Bryostatin-1, NSC 339555, and Cisplatin in Patients With Recurrent and/or Advanced Inoperable Squamous Cell, Adeno or Adenosquamous Cell Carcinoma of the Cervix|
|Study Start Date:||August 2000|
|Study Completion Date:||April 2004|
OBJECTIVES: I. Determine the safety and efficacy of bryostatin-1 plus cisplatin in patients with recurrent or advanced carcinoma of the cervix. II. Determine the response rate, progression free interval, and duration of survival of these patients when treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive bryostatin-1 IV over 1 hour and cisplatin IV over 1 hour on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed until death.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study over 2-3 years.
|United States, New York|
|Albert Einstein Comprehensive Cancer Center|
|Bronx, New York, United States, 10461|
|Mount Sinai Medical Center, NY|
|New York, New York, United States, 10029|
|New York Presbyterian Hospital - Cornell Campus|
|New York, New York, United States, 10021|
|Saint Vincent Catholic Medical Center of New York|
|New York, New York, United States, 10011|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|New York Medical College|
|Valhalla, New York, United States, 10595|
|Study Chair:||Farr R. Nezhat, MD||Mount Sinai School of Medicine|