Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390611
Status:
COMPLETED
Last Update Posted:
2014-12-22
First Post:
2006-10-19
Brief Title:
Paclitaxel and Carboplatin With Or Without Sorafenib In The First-Line Treatment Of Patients With Ovarian Cancer
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
A Randomized Phase II Study of PaclitaxelCarboplatin With or Without Sorafenib in the First-Line Treatment of Patients With Stage IIIIV Epithelial Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2014-12
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:
This trial will compare the efficacy and toxicity of standard first-line chemotherapy alone vs standard chemotherapy plus sorafenib in patients with stage IIIIV ovarian cancer following cytoreductive surgery Patients with residual large volume disease andor bowel involvement will be excluded to minimize the risk of bowel perforation
Detailed Description:
All patients must be at least 4 weeks from cytoreductive surgery before starting treatment Patients will be randomized to receive treatment with either paclitaxelcarboplatin sorafenib or paclitaxelcarboplatin Paclitaxelcarboplatin will be repeated every 21 days for a maximum of 6 cycles Patients with objective responsestable disease after completing 6 courses of chemotherapy will continue sorafenib until disease progression or for a total of 12 months
- Regimen A
Paclitaxel 175 mgm2 1-3 hour IV infusion Day 1
Carboplatin AUC 6 infused over 20 minutes IV Day 1
Sorafenib 400mg PO bid
- Regimen B
Paclitaxel 175mgm2 1-3 hour IV infusion Day 1
Carboplatin AUC 60 20 minute IV infusion Day 1
- Regimen A
Paclitaxel 175 mgm2 1-3 hour IV infusion Day 1
Carboplatin AUC 6 infused over 20 minutes IV Day 1
Sorafenib 400mg PO bid
- Regimen B
Paclitaxel 175mgm2 1-3 hour IV infusion Day 1
Carboplatin AUC 60 20 minute IV infusion Day 1
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 |
|---|---|---|---|
| SR05-918 | None | None | None |