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

Phase 2

Completed

• Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

• Registration Number: NCT00072267
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Study Timeline

• Study First Submitted: 2003-11-04
• Study First Submitted QC: 2003-11-05
• Study First Posted: 2003-11-06
• Study Start: 2004-01
• Primary Completion: 2005-04
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-22
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

Cancer Care Ontario-London Regional Cancer Centre; 🇨🇦 London, Ontario, Canada

Margaret and Charles Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Ottawa Regional Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada