Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114179
Status:
COMPLETED
Last Update Posted:
2020-10-30
First Post:
2005-06-13
Brief Title:
Capecitabine Bevacizumab and Radiation Therapy Followed By Gemcitabine and Bevacizumab in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Bevacizumab With Concurrent Capecitabine and Radiation Followed by Maintenance Gemcitabine and Bevacizumab For Locally Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2020-10
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:
Drugs used in chemotherapy such as capecitabine and gemcitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing 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 Radiation therapy uses high-energy x-rays to kill tumor cells Capecitabine may make tumor cells more sensitive to radiation therapy Bevacizumab may make tumor cells more sensitive to both chemotherapy and radiation therapy Giving chemotherapy and bevacizumab before and after radiation therapy may kill more tumor cells This phase II trial is studying how well giving capecitabine and bevacizumab together with radiation therapy followed by gemcitabine and bevacizumab works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery
Detailed Description:
PRIMARY OBJECTIVES
I Compare 1-year overall survival of patients with unresectable locally advanced pancreatic cancer treated with capecitabine bevacizumab and radiotherapy followed by maintenance therapy comprising gemcitabine and bevacizumab to a historical control
SECONDARY OBJECTIVES
I Determine the frequency of serious unacceptable adverse events in patients treated with this regimen
II Determine the response rate in patients treated with this regimen III Determine the progression-free survival of patients treated with this regimen
OUTLINE This is a multicenter study
Chemoradiotherapy and bevacizumab Patients receive oral capecitabine twice daily and undergo radiotherapy once daily on days 1-5 8-12 15-19 22-26 29-33 and 36-38 Patients also receive bevacizumab IV over 30-90 minutes on days 1 15 and 29 Patients undergo reevaluation 3-4 weeks after completion of chemoradiotherapy and bevacizumab
Patients with no evidence of disease progression proceed to maintenance therapy Patients with a marked response may undergo surgery at the discretion of the attending surgeon and then proceed to maintenance therapy approximately 4-8 weeks later
Maintenance therapy Beginning within 4-7 weeks after completion of chemoradiotherapy and bevacizumab patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 and bevacizumab IV over 30 minutes on days 1 and 15 provided that blood counts have returned to normal Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for survival
PROJECTED ACCRUAL A total of 82 patients will be accrued for this study within 16 months
I Compare 1-year overall survival of patients with unresectable locally advanced pancreatic cancer treated with capecitabine bevacizumab and radiotherapy followed by maintenance therapy comprising gemcitabine and bevacizumab to a historical control
SECONDARY OBJECTIVES
I Determine the frequency of serious unacceptable adverse events in patients treated with this regimen
II Determine the response rate in patients treated with this regimen III Determine the progression-free survival of patients treated with this regimen
OUTLINE This is a multicenter study
Chemoradiotherapy and bevacizumab Patients receive oral capecitabine twice daily and undergo radiotherapy once daily on days 1-5 8-12 15-19 22-26 29-33 and 36-38 Patients also receive bevacizumab IV over 30-90 minutes on days 1 15 and 29 Patients undergo reevaluation 3-4 weeks after completion of chemoradiotherapy and bevacizumab
Patients with no evidence of disease progression proceed to maintenance therapy Patients with a marked response may undergo surgery at the discretion of the attending surgeon and then proceed to maintenance therapy approximately 4-8 weeks later
Maintenance therapy Beginning within 4-7 weeks after completion of chemoradiotherapy and bevacizumab patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 and bevacizumab IV over 30 minutes on days 1 and 15 provided that blood counts have returned to normal Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for survival
PROJECTED ACCRUAL A total of 82 patients will be accrued for this study within 16 months
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 |
|---|---|---|---|
| U10CA021661 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021661 |
| NCI-2012-02661 | REGISTRY | None | None |
| CDR0000434846 | None | None | None |
| RTOG-0411 | OTHER | None | None |
| RTOG-0411 | OTHER | None | None |