Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00447330
Status:
COMPLETED
Last Update Posted:
2015-02-13
First Post:
2007-03-13
Brief Title:
Oxaliplatin Capecitabine and Avastin for Metastatic Esophagogastric Adenocarcinoma
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Phase ll Study of Oxaliplatin Capecitabine and Bevacizumab in the Treatment of Metastatic Esophagogastric Adenocarcinomas
Status:
COMPLETED
Status Verified Date:
2014-07
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:
XAGastric
Brief Summary:
The purpose of this study is to evaluate the progression free survival of capecitabine Xeloda oxaliplatin and bevacizumab Avastin in previously untreated metastatic esophagogastric adenocarcinomas
Detailed Description:
The number of new cases of esophageal and gastric cancers in the United States in 2005 is 14520 for esophageal cancer and 21860 for gastric cancer Unfortunately esophageal and gastric cancers will also account for 13570 and 11550 deaths respectively in 2005 The 5 year survival rates for metastatic gastroesophageal GE junctional and gastric cancers are less than 5 The major current treatment modality for patients with advanced esophageal GE junctional and gastric adenocarcinomas is systemic chemotherapy
We seek to investigate the efficacy of capecitabine and oxaliplatin in combination with bevacizumab as first line treatment for metastatic esophagogastric cancers The choice of capecitabine and oxaliplatin is made to develop a user-friendly biologically-based regimen offering patients oral capecitabine in place of continuous 5FU infusion pumps Since capecitabine can be given crushed this regimen may both be active and user-friendly Preliminary data in colorectal cancer suggest that the regimen of capecitabine oxaliplatin and bevacizumab has comparable activity to FOLFOX-bevacizumab The goal of the proposed regimen is to define a capecitabine and oxaliplatin-based regimen that optimizes biological approaches over cytotoxic approaches The addition of bevacizumab to chemotherapy regimens for metastatic colorectal cancer metastatic non-small cell lung cancer and metastatic breast cancer has shown to improve response rates and overall survival If active this regimen could serve as a first line comparator to the capecitabine oxaliplatin and epirubicin combination This approach will also help to simplify regimen development across gastrointestinal cancers
In addition to the primary efficacy endpoint of this protocol several correlative endpoints will also be examined in an exploratory manner The importance of developing blood-based and tumor biomarkers has been extensively reviewed However the role of such predictive markers has not been well studied for XELOX-A This information is important since it may help define which populations are most likely to benefit and most likely to suffer significant toxicity from this important GI cancer regimen This biomarker approach may also help understand and define mechanisms of sensitivity resistance and toxicity that may be used to guide future hypothesis-driven studies designed to improve the efficacy and safety of this regimen The correlative biomarker endpoints include serum plasma and urine biomarkers eg VEGF and bFGF a wound healing model of angiogenesis and tumor biopsy studies
We seek to investigate the efficacy of capecitabine and oxaliplatin in combination with bevacizumab as first line treatment for metastatic esophagogastric cancers The choice of capecitabine and oxaliplatin is made to develop a user-friendly biologically-based regimen offering patients oral capecitabine in place of continuous 5FU infusion pumps Since capecitabine can be given crushed this regimen may both be active and user-friendly Preliminary data in colorectal cancer suggest that the regimen of capecitabine oxaliplatin and bevacizumab has comparable activity to FOLFOX-bevacizumab The goal of the proposed regimen is to define a capecitabine and oxaliplatin-based regimen that optimizes biological approaches over cytotoxic approaches The addition of bevacizumab to chemotherapy regimens for metastatic colorectal cancer metastatic non-small cell lung cancer and metastatic breast cancer has shown to improve response rates and overall survival If active this regimen could serve as a first line comparator to the capecitabine oxaliplatin and epirubicin combination This approach will also help to simplify regimen development across gastrointestinal cancers
In addition to the primary efficacy endpoint of this protocol several correlative endpoints will also be examined in an exploratory manner The importance of developing blood-based and tumor biomarkers has been extensively reviewed However the role of such predictive markers has not been well studied for XELOX-A This information is important since it may help define which populations are most likely to benefit and most likely to suffer significant toxicity from this important GI cancer regimen This biomarker approach may also help understand and define mechanisms of sensitivity resistance and toxicity that may be used to guide future hypothesis-driven studies designed to improve the efficacy and safety of this regimen The correlative biomarker endpoints include serum plasma and urine biomarkers eg VEGF and bFGF a wound healing model of angiogenesis and tumor biopsy studies
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 |
|---|---|---|---|
| 8797 | OTHER | Duke legacy protocol number | None |
| 11100 | OTHER | None | None |