NCT00072267

UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining UCN-01 with topotecan may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Detailed description

OBJECTIVES: Primary * Determine the antitumor activity of UCN-01 and topotecan, in terms of complete and partial objective response rates, in patients with recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer. Secondary * Determine the antitumor activity of this regimen, in terms of stable disease rates and duration of response, in these patients. * Determine the progression-free, median, and overall survival of patients treated with this regimen. * Determine the safety and tolerability of this regimen in these patients. * Determine the relationship between clinical and pharmacodynamic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive UCN-01 IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 5-11 months.

Conditions

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

Interventions

Type	Name	Description
DRUG	7-hydroxystaurosporine
DRUG	topotecan hydrochloride

Timeline

• Start date: 2004-01-01
• Primary completion: 2005-04-01
• First posted: 2003-11-06
• Last updated: 2015-07-23

Locations

4 sites across 1 country: Canada