Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448136
Status:
COMPLETED
Last Update Posted:
2015-01-22
First Post:
2007-03-15
Brief Title:
A Study of Avastin Bevacizumab in Combination With Chemotherapy in Patients With Endocrine Tumors of the Gastrointestinal Tract
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open Label Study to Evaluate the Effect of Avastin in Association With Chemotherapy on Progression-free Survival in Patients With Progressive AdvancedMetastatic Well-differentiated Digestive Endocrine Tumors of the Gastrointestinal Tract
Status:
COMPLETED
Status Verified Date:
2015-01
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:
This 2 arm study will assess the efficacy and safety of two systemic treatments including Avastin in patients with previously-untreated progressive locally advancedmetastatic well-differentiated digestive endocrine tumors Patients with duodeno-pancreatic tumors arm 1 will be treated with 5FUstreptozotocin iv 5FU 400mgm2d D1 to D5streptozotocin 500mgm2div D1 to D5D1D42 every 6 weeks plus Avastin 75mgkg iv every 3 weeks Patients with gastrointestinal tract tumors arm 2 will be treated with Xeloda 1000mgm2 po bid D1 to D14 plus Avastin 75mgkg iv D1D21 every 3 weeks The patients will be treated with chemotherapy for a minimum of 6 months unless there is tumor progression andor unacceptable toxicity The anticipated time on study treatment is until disease progression or unacceptable toxicity and the target sample size is 100 individuals
Detailed Description:
None
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