Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04787289
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2021-03-01
Brief Title:
A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer
Sponsor:
British Columbia Cancer Agency
Organization:
British Columbia Cancer Agency
Study Overview
Official Title:
A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer - a Pragmatic Trial
Status:
RECRUITING
Status Verified Date:
2024-08
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:
A pragmatic two armed study comparing 2 standard doses of an anti-cancer drug called bevacizumab given in combination with Chemotherapy The study will be offered to ovarian cancer patients whose disease is platinum chemotherapy resistant Higher doses of anti-cancer based drugs are not always better than lower doses and can cause more side effects without improvement of cancer These patients will be randomly assigned either 75 mgkg or 15mgkg of bevacizumab combined with chemotherapy Comparing these two doses will determine if the lower dose-level is non-inferior and could lead to practice changes
Detailed Description:
Study team proposes to compare 2 standard doses of an anti-cancer drug called bevacizumab 75mgkg per dose vs 15mgkg per dose given in combination with chemotherapy in patients with ovarian cancer that progressed on platinum chemotherapy Higher doses in cases of antibody-based drugs like bevacizumab are not always better than lower doses and in fact can cause more side effects without improving survival or shrinkage of cancer Both 75 and 15mgkg doses of bevacizumab every 3 weeks are used as standard protocol in BC Cancer for ovarian cancer patients but only 15mgkg doses are allowed for patients with ovarian cancer that progressed on platinum chemotherapy This study is a pragmatic two-arm blinded study in which 70 patients with platinum-resistant ovarian cancer and eligible for bevacizumab chemotherapy will be randomly assigned either to lower or higher standard dose of bevacizumab combined with chemotherapy Treating clinicians will decide how long the treatment will continue per standard of care Duration of cancer control on CT scans side effect profiles and quality of life related to the two arms will be compared If demonstrated this finding will be practice-changing with comparable efficacy and quality of life potentially improved safety profile as well as reduced provincial drug costs
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