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
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.
Interventional
Primary Purpose: Treatment
Peter G. Rose, MD
Study Chair
The Cleveland Clinic
United States: Federal Government
CDR0000067168
NCT00003967
September 1999
Name | Location |
---|---|
Cooper Hospital/University Medical Center | Camden, New Jersey 08103 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Holden Comprehensive Cancer Center at The University of Iowa | Iowa City, Iowa 52242-1009 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Mercy Medical Center, Inc. | Baltimore, Maryland 21202 |