A Phase I Study of UCN-01 in Combination With Topotecan in Patients With Solid Tumors
- Determine the maximum tolerated dose and recommended phase II dose of UCN-01 and
topotecan in patients with recurrent ovarian epithelial, fallopian tube, or primary
peritoneal cavity cancer.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the relationship between clinical and pharmacokinetic effects of this regimen
in these patients.
OUTLINE: This is a dose-escalation, 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 at least 6 courses in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of UCN-01 and topotecan until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which
at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 12 additional
ovarian epithelial cancer patients are then treated at the recommended phase II dose.
Patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 6-10
Primary Purpose: Treatment
Hal W. Hirte, MD, FRCP(C)
Margaret and Charles Juravinski Cancer Centre
United States: Federal Government