Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100815
Status:
COMPLETED
Last Update Posted:
2015-12-24
First Post:
2005-01-06
Brief Title:
Gemcitabine Capecitabine and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Multicenter Open Label Phase II Clinical Study of Gemcitabine Capecitabine and Avastin in Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2015-11
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 Drugs used in chemotherapy such as gemcitabine and capecitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor cells
PURPOSE This phase II trial is studying how well giving gemcitabine and capecitabine together with bevacizumab works in treating patients with metastatic or unresectable pancreatic cancer
PURPOSE This phase II trial is studying how well giving gemcitabine and capecitabine together with bevacizumab works in treating patients with metastatic or unresectable pancreatic cancer
Detailed Description:
OBJECTIVES
Primary
Determine progression-free survival of patients with metastatic or unresectable adenocarcinoma of the pancreas treated with gemcitabine capecitabine and bevacizumab
Secondary
Determine clinical response in patients treated with this regimen
Determine toxicity of this regimen in these patients
Determine quality of life of patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive bevacizumab IV over 30-90 minutes on day 1 oral capecitabine twice daily on days 1-14 and gemcitabine IV over 30 minutes on days 1 and 8 Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline then weekly for 3 weeks
Patients are followed every 2-4 months for 1 year and then every 6 months for at least 5 years
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study within 88-175 months
Primary
Determine progression-free survival of patients with metastatic or unresectable adenocarcinoma of the pancreas treated with gemcitabine capecitabine and bevacizumab
Secondary
Determine clinical response in patients treated with this regimen
Determine toxicity of this regimen in these patients
Determine quality of life of patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive bevacizumab IV over 30-90 minutes on day 1 oral capecitabine twice daily on days 1-14 and gemcitabine IV over 30 minutes on days 1 and 8 Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline then weekly for 3 weeks
Patients are followed every 2-4 months for 1 year and then every 6 months for at least 5 years
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study within 88-175 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 |
|---|---|---|---|
| GENENTECH-RPCI-I-19903 | None | None | None |
| RPCI-I-19903 | None | None | None |