Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube 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 I trial to study the effectiveness of topotecan plus etoposide in treating patients who have recurrent ovarian cancer, peritoneal cancer, or fallopian tube cancer.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Drug: topotecan hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of Sequential Prolonged Oral Topotecan (IND# 58,131) and Prolonged Oral Etoposide as Second Line Therapy in Ovarian, Peritoneal or Tubal Carcinoma|
|Study Start Date:||September 1999|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the maximum tolerated dose of sequential prolonged topotecan and prolonged etoposide as second line therapy in patients with recurrent ovarian epithelial, peritoneal, or tubal cancer. II. Determine the nature and degree of toxicity of this treatment regimen in this patient population. III. Evaluate the response rate and time to disease progression in these patients.
OUTLINE: This is a dose escalation study. Patients receive oral topotecan daily on days 1-5 and oral etoposide daily on days 8-10. Courses repeat every 28 days in the absence of disease progression or unacceptable side effects. Patients achieving partial or complete response or stable disease continue treatment for at least 4-6 courses. Cohorts of 3-6 patients receive topotecan and etoposide on increasing numbers of days until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no greater than 1 of 6 patients experiences dose limiting toxicity. Patients are followed every 3 months or until death.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003967
|United States, Iowa|
|Holden Comprehensive Cancer Center at The University of Iowa|
|Iowa City, Iowa, United States, 52242-1009|
|United States, Maryland|
|Mercy Medical Center, Inc.|
|Baltimore, Maryland, United States, 21202|
|United States, New Jersey|
|Cooper Hospital/University Medical Center|
|Camden, New Jersey, United States, 08103|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Arthur G. James Cancer Hospital - Ohio State University|
|Columbus, Ohio, United States, 43210-1240|
|Study Chair:||Peter G. Rose, MD||The Cleveland Clinic|