Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227617
Status:
TERMINATED
Last Update Posted:
2023-05-22
First Post:
2005-09-26
Brief Title:
Combination Chemotherapy and Bevacizumab in Treating Patients With Advanced Neuroendocrine Tumors
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Pilot Study of FOLFOX in Combination With Bevacizumab in Patients With Advanced Neuroendocrine Tumors
Status:
TERMINATED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
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 fluorouracil leucovorin and oxaliplatin 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 neuroendocrine tumors by blocking blood flow to the tumor Giving combination chemotherapy together with bevacizumab may kill more tumor cells
PURPOSE This phase III trial is studying the side effects of giving combination chemotherapy together with bevacizumab and to see how well it works in treating patients with advanced neuroendocrine tumors
PURPOSE This phase III trial is studying the side effects of giving combination chemotherapy together with bevacizumab and to see how well it works in treating patients with advanced neuroendocrine tumors
Detailed Description:
OBJECTIVES
Primary
Determine the safety of fluorouracil leucovorin calcium and oxaliplatin FOLFOX with bevacizumab in patients with advanced neuroendocrine tumors
Determine the best overall response rate in patients treated with this regimen
Secondary
Determine the overall survival of patients treated with this regimen
Determine the time to treatment failure and progression in patients treated with this regimen
Determine the biochemical marker response in patients treated with this regimen
OUTLINE This is an open-label pilot study Patients are stratified according to tumor type carcinoid vs islet cell vs poorly differentiated neuroendocrine
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46-48 hours beginning on day 1 Patients also receive bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 14 days for up to 26 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 39-102 patients 13-34 per stratum will be accrued for this study
Primary
Determine the safety of fluorouracil leucovorin calcium and oxaliplatin FOLFOX with bevacizumab in patients with advanced neuroendocrine tumors
Determine the best overall response rate in patients treated with this regimen
Secondary
Determine the overall survival of patients treated with this regimen
Determine the time to treatment failure and progression in patients treated with this regimen
Determine the biochemical marker response in patients treated with this regimen
OUTLINE This is an open-label pilot study Patients are stratified according to tumor type carcinoid vs islet cell vs poorly differentiated neuroendocrine
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46-48 hours beginning on day 1 Patients also receive bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 14 days for up to 26 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 39-102 patients 13-34 per stratum will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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-2011-01214 | REGISTRY | NCI Clinical Trials Reporting Program | None |