UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
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|ClinicalTrials.gov Identifier: NCT00045175|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 23, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Drug: 7-hydroxystaurosporine Drug: topotecan hydrochloride||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of UCN-01 in Combination With Topotecan in Patients With Solid Tumors|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||June 2013|
|Experimental: UCN-01 in combination with topotecan||Drug: 7-hydroxystaurosporine Drug: topotecan hydrochloride|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00045175
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Care Ontario-London Regional Cancer Centre|
|London, Ontario, Canada, N6A 4L6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Hal W. Hirte, MD, FRCP(C)||Margaret and Charles Juravinski Cancer Centre|