Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072267
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2003-11-04
Brief Title:
UCN-01 and Topotecan in Treating Patients With Recurrent Persistent or Progressive Advanced Ovarian Epithelial Primary Peritoneal or Fallopian Tube Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Primary
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
Secondary
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
Primary
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
Secondary
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000339563 | REGISTRY | None | None |
| NCI-6402 | Registry Identifier | PDQ Physician Data Query | None |