Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227773
Status:
WITHDRAWN
Last Update Posted:
2015-10-08
First Post:
2005-09-26
Brief Title:
Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Study of Vatalanib and Octreotide in Patients With Progressive Low-Grade Neuroendocrine Tumors
Status:
WITHDRAWN
Status Verified Date:
2015-10
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 Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by stopping blood flow to the tumor Octreotide may help control symptoms such as diarrhea caused by the tumor Giving vatalanib together with octreotide may be an effective treatment for neuroendocrine tumors
PURPOSE This phase II trial is studying how well giving vatalanib together with octreotide works in treating patients with progressive neuroendocrine tumors
PURPOSE This phase II trial is studying how well giving vatalanib together with octreotide works in treating patients with progressive neuroendocrine tumors
Detailed Description:
OBJECTIVES
Determine the 4-month progression-free and overall survival of patients with progressive low-grade neuroendocrine tumors treated with vatalanib and octreotide
Determine the response rate in patients treated with this regimen
Determine the effect of this regimen on tumor markers eg chromogranin A 5-HIAA and gastrin in these patients
Determine the toxicity and tolerability of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral vatalanib once daily on days 1- 28 and octreotide intramuscularly or IV on day 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
NOTE Patients on a stable dose ie no changes in dosage within the past 3 months of octreotide before study entry remain on their current dose and schedule during study participation patients who experience hypersensitivity andor toxicity to octreotide may receive vatalanib alone
After completion of study treatment patients are followed at 4 weeks every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 23-44 patients will be accrued for this study within 3 years
Determine the 4-month progression-free and overall survival of patients with progressive low-grade neuroendocrine tumors treated with vatalanib and octreotide
Determine the response rate in patients treated with this regimen
Determine the effect of this regimen on tumor markers eg chromogranin A 5-HIAA and gastrin in these patients
Determine the toxicity and tolerability of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral vatalanib once daily on days 1- 28 and octreotide intramuscularly or IV on day 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
NOTE Patients on a stable dose ie no changes in dosage within the past 3 months of octreotide before study entry remain on their current dose and schedule during study participation patients who experience hypersensitivity andor toxicity to octreotide may receive vatalanib alone
After completion of study treatment patients are followed at 4 weeks every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 23-44 patients will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ECOG-E6203 | None | None | None |