Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112528
Status:
COMPLETED
Last Update Posted:
2016-12-13
First Post:
2005-06-02
Brief Title:
Bevacizumab Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial of Bevacizumab Gemcitabine Oxaliplatin in Patients With Metastatic Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2016-12
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:
RATIONALE Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor Drugs used in chemotherapy such as gemcitabine and oxaliplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving bevacizumab together with gemcitabine and oxaliplatin may kill more tumor cells
PURPOSE This phase II trial is studying how well giving bevacizumab together with gemcitabine and oxaliplatin works in treating patients with metastatic pancreatic cancer
PURPOSE This phase II trial is studying how well giving bevacizumab together with gemcitabine and oxaliplatin works in treating patients with metastatic pancreatic cancer
Detailed Description:
OBJECTIVES
Primary
Determine the 6-month survival of patients with metastatic adenocarcinoma of the pancreas treated with bevacizumab gemcitabine and oxaliplatin
Secondary
Determine the objective response rate in patients with measurable disease treated with this regimen
Determine median survival progression-free survival time to treatment failure and overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 100 minutes and bevacizumab IV over 30-90 minutes on days 1 and 15 Patients also receive oxaliplatin IV over 120 minutes on days 2 and 16 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 courses of therapy beyond CR
After completion of study treatment patients are followed every 3-6 months for up to 5 years
Primary
Determine the 6-month survival of patients with metastatic adenocarcinoma of the pancreas treated with bevacizumab gemcitabine and oxaliplatin
Secondary
Determine the objective response rate in patients with measurable disease treated with this regimen
Determine median survival progression-free survival time to treatment failure and overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 100 minutes and bevacizumab IV over 30-90 minutes on days 1 and 15 Patients also receive oxaliplatin IV over 120 minutes on days 2 and 16 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 courses of therapy beyond CR
After completion of study treatment patients are followed every 3-6 months for up to 5 years
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 |
|---|---|---|---|
| CDR0000430845 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02655 | REGISTRY | None | None |