Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University Health Network, Toronto
With
OBJECTIVES: * 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 months.
Age
18–120
Sex
FEMALE
Healthy volunteers
Not accepted
