Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460174
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2007-04-11
Brief Title:
Gemcitabine Bevacizumab and Abdominal Radiation Therapy in Treating Patients With Localized Pancreatic Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase II Trial of Weekly Gemcitabine Hydrochloride and Bevacizumab in Combination With Abdominal Radiation Therapy in Patients With Localized Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2018-10
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:
RATIONALE Drugs used in chemotherapy such as 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 tumor growth by blocking blood flow to the tumor Radiation therapy uses high-energy x-rays to kill tumor cells Gemcitabine and bevacizumab may make tumor cells more sensitive to radiation therapy Giving gemcitabine together with bevacizumab and radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving gemcitabine together with bevacizumab and abdominal radiation therapy works in treating patients with localized pancreatic cancer
PURPOSE This phase II trial is studying how well giving gemcitabine together with bevacizumab and abdominal radiation therapy works in treating patients with localized pancreatic cancer
Detailed Description:
OBJECTIVES
Primary
Determine the objective response rate in patients treated with concurrent bevacizumab gemcitabine hydrochloride and abdominal radiotherapy
Secondary
Determine the quantitative toxicity associated with the delivery of this regimen in these patients
Determine the 1-year and median survival of patients treated with this regimen
Determine the time to progression in patients treated with this regimen
Determine the patterns of recurrence in the entire population of patients treated with this regimen and in the subgroup that is resected for cure
Determine the safety of this regimen in these patients
Evaluate the surgical experience of patients who undergo surgical resection after completion of protocol-directed therapy
Evaluate the toxicity associated with surgical resection in these patients
OUTLINE Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 of courses 1 and 3 and on days 1 8 and 15 of course 2 Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15 of course 1 on days 8 and 22 of course 2 and on day 8 of course 3 Treatment repeats every 3-4 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity Beginning on day 1 of the second course of chemotherapy patients undergo concurrent abdominal radiotherapy once daily five days a week for 3 weeks
Patients are evaluated at week 10 Patients whose disease deemed resectable after study treatment undergo standard pancreatic resection at least 6 weeks after completion of bevacizumab Patients who remain unresectable and have not progressed after completion of chemoradiotherapy may begin maintenance therapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1 8 and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15 Treatment with gemcitabine hydrochloride and bevacizumab repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed periodically for up to 10 years
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine the objective response rate in patients treated with concurrent bevacizumab gemcitabine hydrochloride and abdominal radiotherapy
Secondary
Determine the quantitative toxicity associated with the delivery of this regimen in these patients
Determine the 1-year and median survival of patients treated with this regimen
Determine the time to progression in patients treated with this regimen
Determine the patterns of recurrence in the entire population of patients treated with this regimen and in the subgroup that is resected for cure
Determine the safety of this regimen in these patients
Evaluate the surgical experience of patients who undergo surgical resection after completion of protocol-directed therapy
Evaluate the toxicity associated with surgical resection in these patients
OUTLINE Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 of courses 1 and 3 and on days 1 8 and 15 of course 2 Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15 of course 1 on days 8 and 22 of course 2 and on day 8 of course 3 Treatment repeats every 3-4 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity Beginning on day 1 of the second course of chemotherapy patients undergo concurrent abdominal radiotherapy once daily five days a week for 3 weeks
Patients are evaluated at week 10 Patients whose disease deemed resectable after study treatment undergo standard pancreatic resection at least 6 weeks after completion of bevacizumab Patients who remain unresectable and have not progressed after completion of chemoradiotherapy may begin maintenance therapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1 8 and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15 Treatment with gemcitabine hydrochloride and bevacizumab repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed periodically for up to 10 years
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| NU-04I6 | None | None | None |
| STU00006774 | OTHER | Northwestern University IRB | None |