NCT00003967

Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 I trial to study the effectiveness of topotecan plus etoposide in treating patients who have recurrent ovarian cancer, peritoneal cancer, or fallopian tube cancer.

Detailed description

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.

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
DRUG	etoposide
DRUG	topotecan hydrochloride

Timeline

• Start date: 1999-09-01
• Primary completion: 2006-04-01
• First posted: 2004-03-31
• Last updated: 2013-05-27

Locations

6 sites across 1 country: United States