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A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian Cancer
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.
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Start Date
January 1, 2004
Primary Completion Date
April 1, 2005
Last Updated
July 23, 2015
7-hydroxystaurosporine
DRUG
topotecan hydrochloride
DRUG
Lead Sponsor
University Health Network, Toronto
Collaborators
NCT04550494
NCT05039801
Data Source & Attribution
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