Ovarian Cancer Clinical Trial
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
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.
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.
;
Primary Purpose: Treatment
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