Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045175
Status:
COMPLETED
Last Update Posted:
2016-06-23
First Post:
2002-09-06
Brief Title:
UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer Fallopian Tube Cancer or Primary Peritoneal Cavity Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase I Study of UCN-01 in Combination With Topotecan in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2016-06
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 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
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
Detailed Description:
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
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 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 |
|---|---|---|---|
| NCI-5518 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000256917 | REGISTRY | None | None |