UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
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.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Drug: topotecan hydrochloride
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|