A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Hal W. Hirte, MD, FRCP(C)
Principal Investigator
Margaret and Charles Juravinski Cancer Centre
United States: Federal Government
CDR0000339563
NCT00072267
January 2004
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