Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-27 @ 9:59 PM
Study NCT ID:
NCT00393861
Status:
COMPLETED
Last Update Posted:
2016-03-24
First Post:
2006-10-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Oxaliplatin Plus Bevacizumab in Germ Cell Tumor Patients
Sponsor:
Indiana University
Organization:
Study Overview
Official Title:
Phase II Study of Oxaliplatin Plus Bevacizumab Salvage Chemotherapy in Patients With Germ Cell Tumors
Status:
COMPLETED
Status Verified Date:
2016-02
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 effectiveness of oxaliplatin and bevacizumab in patients with refractory or relapsed germ cell tumors.
Detailed Description:
This study proposes to look at the established combination of oxaliplatin and bevacizumab as used in colorectal cancer in refractory germ cell tumor patients. Oxaliplatin is a drug of known activity. Although bevacizumab has no single agent data, it combines dramatically well with numerous chemotherapy drugs, such as oxaliplatin increasing response rates and improving survival. Furthermore, VEG-F appears to be an important target in germ cell tumors as it does in so many other types of solid tumors. We will be using the identical dosages of oxaliplatin + bevacizumab as has been utilized in previously treated colorectal cancer, without the addition of 5-FU + leucovorin. This dose and schedule has been proven to be safe and effective.
Study Oversight
Has Oversight DMC:
True
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?: