Ovarian Cancer Clinical Trial
Official title:
A Phase I Study of UCN-01 in Combination With Topotecan in Patients With Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Topotecan may stop the growth of tumor cells by blocking the
enzymes necessary for tumor cell growth. Combining chemotherapy with topotecan may kill more
tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with topotecan in
treating patients who have recurrent ovarian epithelial cancer, fallopian tube cancer, or
primary peritoneal cavity cancer.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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