Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT00360360
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2006-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Carcinoma of Unknown Primary Site
Sponsor:
SCRI Development Innovations, LLC
Organization:
Study Overview
Official Title:
A Phase II Study of Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib 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 (paclitaxel/carboplatin)plus combination targeted therapy (bevacizumab/erlotinib)in 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 and/or the EGFR pathway are effective strategies in at least a proportion.
Detailed Description:
All eligible patients will receive:
* Bevacizumab 15mg/kg IV infusion,Day 1
* Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1
* Carboplatin AUC 6.0 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 paclitaxel/carboplatin and continue treatment with bevacizumab/erlotinib until tumor progression is documented for a maximum of 12 months. During treatment with bevacizumab/erlotinib response will be evaluated every 12 weeks.
* Bevacizumab 15mg/kg IV infusion,Day 1
* Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1
* Carboplatin AUC 6.0 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 paclitaxel/carboplatin and continue treatment with bevacizumab/erlotinib until tumor progression is documented for a maximum of 12 months. During treatment with bevacizumab/erlotinib response will be evaluated every 12 weeks.
Study Oversight
Has Oversight DMC:
False
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?: