Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369889
Status:
COMPLETED
Last Update Posted:
2014-06-03
First Post:
2006-08-28
Brief Title:
A Study to Test the Safety and Efficacy of Erlotinib Plus Bevacizumab to Treat Advanced Thymoma and Thymic Cancer
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
A Phase II Study of Erlotinib Plus Bevacizumab in the Treatment of Advanced Thymoma and Thymic Carcinoma
Status:
COMPLETED
Status Verified Date:
2014-05
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 determine the rate of response with the combination of erlotinib and bevacizumab in previously treated patients with thymoma or thymic carcinoma and to determine potential molecular markers that may predict response to therapy in patients with thymoma or thymic carcinoma
Detailed Description:
We believe that both the EGFR pathway as well as tumor angiogenesis play an important role in the pathogenesis of thymic neoplasms Our previous experience with the EGFR inhibitor gefitinib showed a promising though limited activity in this disease We hypothesize that combining the novel EGFR inhibitor erlotinib with bevacizumab will have a synergistic effect on this tumor We have selected the 15mgkg q21 days of bevacizumab based on the data published by Johnson DH et al in which 99 patients were randomly assigned to bevacizumab 75 n 32 or 15 mgkg n 35 plus carboplatin area under the curve 6 and paclitaxel 200 mgm2 every 3 weeks or carboplatin and paclitaxel alone n 32 The highest response noted in the high-dose group 315 and 281 in the lower dose bevacizumab arm There was also a trend to improved TTP and OS in the high dose arm although the study lacked sufficient power to make any definitive conclusions regarding a possible relationship between dose and treatment effect 105 The safety and efficacy of this dose and schedule was confirmed by E4599 43 Herbst et al have confirmed the safety of the combination of erlotinib 150 mgday orally plus bevacizumab 15 mgkg in a published phase III trial 74
This regimen has the potential to provide a new effective therapy for this malignancy as well as teaching us important lessons about the biology of the disease To this end we would also measure surrogate markers of angiogenesis such as tumor VEGF expression serum VCAM-1 and bFGF as well as urine VEGF We would also determine tumor expression of phosphorylated EGFR and analyze the effect of known variant polymorphisms in the VEGF gene on outcomes We will test tumor samples for expression of EGFR by IHC and FISH to correlate to response
This regimen has the potential to provide a new effective therapy for this malignancy as well as teaching us important lessons about the biology of the disease To this end we would also measure surrogate markers of angiogenesis such as tumor VEGF expression serum VCAM-1 and bFGF as well as urine VEGF We would also determine tumor expression of phosphorylated EGFR and analyze the effect of known variant polymorphisms in the VEGF gene on outcomes We will test tumor samples for expression of EGFR by IHC and FISH to correlate to response
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 |
|---|---|---|---|
| IUCRO-0148 | OTHER | IU Simon Cancer Center | None |
| AVF3891s | OTHER | None | None |