Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-27 @ 11:51 PM
Study NCT ID:
NCT00028834
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2002-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase II Trial Of Bevacizumab (NSC#704865) Plus Gemcitabine In Patients With Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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 phase II trial is to see if combining gemcitabine with bevacizumab works in treating patients who have advanced pancreatic cancer. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with a monoclonal antibody may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the objective response rate of patients with advanced pancreatic cancer who are treated with gemcitabine plus bevacizumab.
II. To determine the toxicity experienced by patients with advanced pancreatic cancer who are treated with gemcitabine plus bevacizumab.
III. To determine median and overall survival of patients with advanced pancreatic cancer who are treated with gemcitabine plus bevacizumab.
SECONDARY OBJECTIVES:
I. To measure plasma VEGF and serum VCAM-1 levels before, during, and after therapy as a predictor of outcome.
II. To collect and store serum samples for possible future assessment of other antiangiogenic inhibition markers.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
I. To determine the objective response rate of patients with advanced pancreatic cancer who are treated with gemcitabine plus bevacizumab.
II. To determine the toxicity experienced by patients with advanced pancreatic cancer who are treated with gemcitabine plus bevacizumab.
III. To determine median and overall survival of patients with advanced pancreatic cancer who are treated with gemcitabine plus bevacizumab.
SECONDARY OBJECTIVES:
I. To measure plasma VEGF and serum VCAM-1 levels before, during, and after therapy as a predictor of outcome.
II. To collect and store serum samples for possible future assessment of other antiangiogenic inhibition markers.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 11255B | None | None | View | |
| N01CM17102 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDR0000069138 | REGISTRY | PDQ (Physician Data Query) | View |