Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360360
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2006-08-02
Brief Title:
PaclitaxelCarboplatin Plus BevacizumabErlotinib in the First Line Treatment of Carcinoma of Unknown Primary Site
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
A Phase II Study of PaclitaxelCarboplatin Plus BevacizumabErlotinib in the First Line Treatment of Patients With Carcinoma of Unknown Primary Site
Status:
COMPLETED
Status Verified Date:
2013-11
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:
We will evaluate the feasibility toxicity and effectiveness of combination chemotherapy paclitaxelcarboplatinplus combination targeted therapy bevacizumaberlotinibin the first line treatment of patients with carcinoma of unknown primary site There is limited experience with either bevacizumab or erlotinib in the treatment of cancers of unknown site but given the heterogeneous nature of the tumor it is likely that inhibition of angiogenesis pathways andor the EGFR pathway are effective strategies in at least a proportion
Detailed Description:
All eligible patients will receive
Bevacizumab 15mgkg IV infusionDay 1
Paclitaxel 175mgm2 1-3 hour IV infusionDay 1
Carboplatin AUC 60 IV Day 1
Erlotinib 150 mg by mouth daily
The regimen will be repeated every 21 days for a total of 4 courses Patients will be initially evaluated for response after completing 2 courses 6 weeks of treatment Patients with an objective tumor response or stable disease will continue treatment for another 2 courses Patients will be re-evaluated after 4 courses and those with objective tumor response or stable disease will stop chemotherapy with paclitaxelcarboplatin and continue treatment with bevacizumaberlotinib until tumor progression is documented for a maximum of 12 months During treatment with bevacizumaberlotinib response will be evaluated every 12 weeks
Bevacizumab 15mgkg IV infusionDay 1
Paclitaxel 175mgm2 1-3 hour IV infusionDay 1
Carboplatin AUC 60 IV Day 1
Erlotinib 150 mg by mouth daily
The regimen will be repeated every 21 days for a total of 4 courses Patients will be initially evaluated for response after completing 2 courses 6 weeks of treatment Patients with an objective tumor response or stable disease will continue treatment for another 2 courses Patients will be re-evaluated after 4 courses and those with objective tumor response or stable disease will stop chemotherapy with paclitaxelcarboplatin and continue treatment with bevacizumaberlotinib until tumor progression is documented for a maximum of 12 months During treatment with bevacizumaberlotinib response will be evaluated every 12 weeks
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