UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
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|ClinicalTrials.gov Identifier: NCT00072267|
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : July 23, 2015
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining UCN-01 with topotecan may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Drug: 7-hydroxystaurosporine Drug: topotecan hydrochloride||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian Cancer|
|Study Start Date :||January 2004|
|Primary Completion Date :||April 2005|
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): NCT00072267
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Care Ontario-London Regional Cancer Centre|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Regional Cancer Centre|
|Ottawa, Ontario, Canada, K1H 8L6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Hal W. Hirte, MD, FRCP(C)||Margaret and Charles Juravinski Cancer Centre|