Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343044
Status:
COMPLETED
Last Update Posted:
2015-05-15
First Post:
2006-06-20
Brief Title:
Ph II Study of Wkly Topotecan Bevacizumab in Plat ResistantRecurrent Gyn Cancers
Sponsor:
Benaroya Research Institute
Organization:
Benaroya Research Institute
Study Overview
Official Title:
Phase II Study of Weekly Topotecan With Bevacizumab in Platinum Resistant Recurrent Ovarian Fallopian Tube and Primary Peritoneal Cancers
Status:
COMPLETED
Status Verified Date:
2015-04
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:
The purpose of this study is to evaluate the clinical safety and toxicity of intravenous bevacizumab Days 1 and 15 of a 28 day cycle in combination with weekly topotecan Days 1 8 15 of a 28 day cycle in patients with platinum resistant recurrent ovarian fallopian tube and primary peritoneal cancer
Detailed Description:
This study is designed as a Phase 2 study There are no published data on the toxicity of the combination of bevacizumab and topotecan therapy Based on data combining bevacizumab with other chemotherapy agents in non-gynecologic solid tumors it is not likely that the toxicity of the combination of the two drugs will be greater than the individual toxicities of each drug The toxicities of each of these agents is quite different Specifically the toxicity of this combination will be studied using the dose of bevacizumab used in previous phase II studies of ovarian cancer eg an equivalent of 5 mgkg weekly with treatments given at least every 3 weeks In our study since topotecan will be given weeks 12 and 3 of an every 4 week cycle it is convenient to give bevacizumab 10 mgkg IV every other week
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 |
|---|---|---|---|
| AVF3648s | OTHER | GSK | None |