Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010179
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2001-02-02
Brief Title:
Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
Randomized Phase II Study Of NX 211 Given By Two Different Intravenous Schedules In Advanced AndOr Recurrent Epithelial Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
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 of die
PURPOSE Randomized phase II trial to compare the effectiveness of two treatment regimens of lurtotecan liposome in patients who have advanced or recurrent ovarian epithelial cancer primary fallopian tube cancer or peritoneal cancer that has been previously treated with chemotherapy
PURPOSE Randomized phase II trial to compare the effectiveness of two treatment regimens of lurtotecan liposome in patients who have advanced or recurrent ovarian epithelial cancer primary fallopian tube cancer or peritoneal cancer that has been previously treated with chemotherapy
Detailed Description:
OBJECTIVES I Compare the anti-tumor efficacy of two treatment schedules of lurtotecan liposome in terms of clinicalradiological response and CA125 tumor marker in patients with previously treated advanced or recurrent ovarian epithelial cancer II Compare the safety pharmacokinetics and possible pharmacokineticpharmacodynamic relationships of these treatment schedules in these patients III Compare the time to progression in patients treated with these treatment schedules
OUTLINE This is a randomized multicenter study Patients are stratified according to time from last prior chemotherapy less than 6 months vs 6 months or more and number of prior chemotherapy regimens 1 vs 2 Patients are randomized to one of two treatment arms Arm I Patients receive lurtotecan liposome IV over 30 minutes on days 1-3 Arm II Patients receive lurtotecan liposome IV over 30 minutes on days 1 and 8 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 2 additional courses after documented CR Patients achieving partial response PR receive 4 additional courses after documented PR or until disease progression at investigators discretion Patients with stable disease continue therapy for a maximum of 6 courses Patients are followed at 4 weeks and then every 3 months until disease relapse or progression
PROJECTED ACCRUAL A total of 40-74 patients 20-37 per treatment arm will be accrued for this study within 10 months
OUTLINE This is a randomized multicenter study Patients are stratified according to time from last prior chemotherapy less than 6 months vs 6 months or more and number of prior chemotherapy regimens 1 vs 2 Patients are randomized to one of two treatment arms Arm I Patients receive lurtotecan liposome IV over 30 minutes on days 1-3 Arm II Patients receive lurtotecan liposome IV over 30 minutes on days 1 and 8 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 2 additional courses after documented CR Patients achieving partial response PR receive 4 additional courses after documented PR or until disease progression at investigators discretion Patients with stable disease continue therapy for a maximum of 6 courses Patients are followed at 4 weeks and then every 3 months until disease relapse or progression
PROJECTED ACCRUAL A total of 40-74 patients 20-37 per treatment arm will be accrued for this study within 10 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CAN-NCIC-IND138 | OTHER | None | None |
| CDR0000068453 | OTHER | PDQ | None |