Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04753216
Status:
COMPLETED
Last Update Posted:
2023-01-19
First Post:
2021-02-10
Brief Title:
Irinotecan Liposome and Bevacizumab for the Treatment of Platinum Resistant Recurrent or Refractory Ovarian Fallopian Tube or Primary Peritoneal Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase II Trial of Irinotecan Liposome and Bevacizumab in Women With Platinum Resistant Ovarian Fallopian Tube or Primary Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial investigates the effect of irinotecan liposome and bevacizumab in treating patients with ovarian fallopian tube or primary peritoneal cancer that shows less response to platinum therapy platinum resistant has come back recurrent or does not respond to treatment refractory Irinotecan liposome may help block the formation of growths that may become cancer Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread Giving irinotecan liposome and bevacizumab may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVE
I To assess the antineoplastic efficacy of irinotecan sucrosofate irinotecan liposome in combination with bevacizumab in women with recurrent platinum resistant ovarian cancer as measured by the objective response rate ORR
SECONDARY EFFICACY OBJECTIVES
I To determine the overall best response per Response Evaluation Criteria in Solid Tumors RECIST 11 in women with recurrent platinum resistant ovarian cancer who have received treatment with irinotecan liposome in combination with bevacizumab
II To determine the clinical benefit rate CBR for irinotecan liposome in combination with bevacizumab in women with recurrent platinum resistant ovarian cancer
III To calculate the duration of response DOR for irinotecan liposome in combination with bevacizumab in women with recurrent platinum resistant ovarian cancer
IV To calculate the duration of stable disease duration of SD for irinotecan liposome in combination with bevacizumab in women with recurrent platinum resistant ovarian cancer
V To calculate the time to response TTR for irinotecan liposome in combination with bevacizumab in women with recurrent platinum resistant ovarian cancer
VI To measure median progression-free survival PFS in women with recurrent platinum resistant ovarian cancer who have received treatment with irinotecan liposome in combination with bevacizumab
VII To measure 16 week progression-free survival PFS-16 in women with recurrent platinum resistant ovarian cancer who have received treatment with irinotecan liposome in combination with bevacizumab
SECONDARY SAFETY OBJECTIVE
I To assess the toxicity profile of irinotecan liposome in combination with bevacizumab in women with recurrent platinum resistant ovarian cancer according to National Cancer Institute NCI-Common Terminology Criteria for Adverse Events CTCAE version v50
OUTLINE
Patients receive bevacizumab intravenously IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days every 3 months for 1 year and then every 6 months for 2 years
I To assess the antineoplastic efficacy of irinotecan sucrosofate irinotecan liposome in combination with bevacizumab in women with recurrent platinum resistant ovarian cancer as measured by the objective response rate ORR
SECONDARY EFFICACY OBJECTIVES
I To determine the overall best response per Response Evaluation Criteria in Solid Tumors RECIST 11 in women with recurrent platinum resistant ovarian cancer who have received treatment with irinotecan liposome in combination with bevacizumab
II To determine the clinical benefit rate CBR for irinotecan liposome in combination with bevacizumab in women with recurrent platinum resistant ovarian cancer
III To calculate the duration of response DOR for irinotecan liposome in combination with bevacizumab in women with recurrent platinum resistant ovarian cancer
IV To calculate the duration of stable disease duration of SD for irinotecan liposome in combination with bevacizumab in women with recurrent platinum resistant ovarian cancer
V To calculate the time to response TTR for irinotecan liposome in combination with bevacizumab in women with recurrent platinum resistant ovarian cancer
VI To measure median progression-free survival PFS in women with recurrent platinum resistant ovarian cancer who have received treatment with irinotecan liposome in combination with bevacizumab
VII To measure 16 week progression-free survival PFS-16 in women with recurrent platinum resistant ovarian cancer who have received treatment with irinotecan liposome in combination with bevacizumab
SECONDARY SAFETY OBJECTIVE
I To assess the toxicity profile of irinotecan liposome in combination with bevacizumab in women with recurrent platinum resistant ovarian cancer according to National Cancer Institute NCI-Common Terminology Criteria for Adverse Events CTCAE version v50
OUTLINE
Patients receive bevacizumab intravenously IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days every 3 months for 1 year and then every 6 months for 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| STU00213582 | None | None | None |
| NU 20G02 | OTHER | None | None |
| P30CA060553 | NIH | None | None |
| NCI-2021-00765 | REGISTRY | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchP30CA060553 |