Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120172
Status:
TERMINATED
Last Update Posted:
2007-11-16
First Post:
2005-07-08
Brief Title:
Study of Oxaliplatin Capecitabine and Bevacizumab to Treat Older Patients With Colorectal Cancer
Sponsor:
Geriatric Oncology Consortium
Organization:
Geriatric Oncology Consortium
Study Overview
Official Title:
A Phase II Study of Oxaliplatin Capecitabine and Bevacizumab in the Treatment of Elderly Patients With Metastatic Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
positive results from a larger study with same regimen was released
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Currently there is no one standard of care for older patients with metastatic colorectal cancer The study will examine the tumor response to capecitabine oxaliplatin plus bevacizumab The study will also gather information on the usefulness and side effects of this treatment combination
Detailed Description:
Colorectal cancer is primarily a disease of the elderly with the median age in the United States of 70 years Age greater than 65 years at presentation is not a contraindication to standard therapies acceptable morbidity and mortality as well as long term survival are achieved in this patient population However studies evaluating combination therapy have generally involved younger patients with high performance status scores Given the non-over-lapping safety profiles of the proposed study agents and the potential synergy it would be of benefit to explore the combination of oxaliplatin capecitabine and bevacizumab in the treatment of older patients with colorectal cancer Time to progression overall response duration of response and toxicity profile will be evaluated The feasibility of using a self-report geriatric assessment tool will also be assessed
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