Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417976
Status:
COMPLETED
Last Update Posted:
2015-10-01
First Post:
2007-01-02
Brief Title:
Gemcitabine Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer
Sponsor:
Tony Bekaii-Saab
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study of the Combination of Fixed Dose Rate Gemcitabine Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer
Status:
COMPLETED
Status Verified Date:
2015-09
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 is a phase II study of biweekly every other week bevacizumab followed by gemcitabine then infusional 5-fluorouracil in patients with stage III or IV pancreatic cancer Patients response will be evaluated every 8 weeks using usual CT scanning techniques RECIST Response Evaluation Criteria in Solid tumors criteria will be applied to evaluate response Tumor marker levels Ca 19-9 will be assessed every 4 weeks but will not be used to measure response
Detailed Description:
Rationale Research indicates that the vascular endothelial growth factor VEGF or a substance made by cells that stimulates new blood vessel formation plays an important role in the growth and metastasis of many cancers including pancreatic carcinoma Both VEGF and its receptors are overexpressed in pancreatic cancer Bevacizumab works by blocking VEGF and the growth of cancer cells in the process The current study combines bevacizumab with two commonly used pancreatic cancer drugs gemcitabine and infusional 5-FU Previous studies indicate that bevacizumab combined with other anti-cancer drugs such as 5-FU improves patient survival In addition other research suggests that the drug administration schedule of the current study may improve patient outcomes compared to other types of administration and sequencing
Purpose The primary objective of this study is to assess the rate of progression free survival at 6 months in patients with advanced pancreatic cancer given gemcitabine infusional 5-FU and bevacizumab Secondary objectives of this study include measuring response rates 6 month and 1-year survival rates and median overall survival
Treatment Study participants will be given bevacizumab gemcitabine and 5-FU These drugs will be administered through intravenous infusions in that order every other week on days 1 and 15 Treatments will be given in 28-day cycles Participants will therefore receive study drugs during weeks 1 and 3 and then receive no study drugs during weeks 2 and 4 Imaging exams will be performed every 8 weeks to assess disease size Several other tests will be given throughout the study to closely monitor patients Tumor level markers will be assessed every 4 weeks but will not be used to measure response Study treatments will be discontinued due to disease growth or severe adverse effects
Purpose The primary objective of this study is to assess the rate of progression free survival at 6 months in patients with advanced pancreatic cancer given gemcitabine infusional 5-FU and bevacizumab Secondary objectives of this study include measuring response rates 6 month and 1-year survival rates and median overall survival
Treatment Study participants will be given bevacizumab gemcitabine and 5-FU These drugs will be administered through intravenous infusions in that order every other week on days 1 and 15 Treatments will be given in 28-day cycles Participants will therefore receive study drugs during weeks 1 and 3 and then receive no study drugs during weeks 2 and 4 Imaging exams will be performed every 8 weeks to assess disease size Several other tests will be given throughout the study to closely monitor patients Tumor level markers will be assessed every 4 weeks but will not be used to measure response Study treatments will be discontinued due to disease growth or severe adverse effects
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 |
|---|---|---|---|
| NCI-2011-03230 | REGISTRY | CTRP Clinical Trial Reporting Program | None |