Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00427349
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2007-01-25
Brief Title:
AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Clinical and Biologic Study of AMG 706 and Octreotide in Patients With Low-Grade Neuroendocrine Tumors
Status:
COMPLETED
Status Verified Date:
2023-06
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 AMG 706 and octreotide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
PURPOSE This phase II trial is studying how well AMG 706 and octreotide work in treating patients with low-grade neuroendocrine tumors
PURPOSE This phase II trial is studying how well AMG 706 and octreotide work in treating patients with low-grade neuroendocrine tumors
Detailed Description:
OBJECTIVES
Primary
Determine the 4-month progression-free survival PFS of patients with low-grade neuroendocrine tumors treated with AMG 706 and octreotide acetate
Secondary
Determine the response rate and overall survival of patients treated with these drugs
Determine the toxicity and tolerability of AMG 706 in these patients
Determine the effect of AMG 706 on tumor perfusion by functional computerized tomography CT scan
Determine the effect of AMG 706 on tumor markers eg chromogranin A 5-hydroxyindoleacetic acid and gastrin specific for neuroendocrine tumors
Determine the effect of AMG 706 on serum vascular endothelial growth factor VEGF levels
Determine the expression of VEGF VEGF receptor-2 VEGFR-2 chromogranin A human achaete-scute homolog-1 hASH1 and Notch1 markers of neuroendocrine tumors
OUTLINE This is a multicenter study
Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Plasma samples are collected at baseline periodically during study treatment and at 4 weeks after the completion of study treatment Samples are used to determine plasma VEGF levels Gene expression of downstream markers of Raf kinase expression raf MEK and ERK as well as hASH1 and Notch1 are evaluated at baseline Tumor tissue collected at diagnosis or prior surgery is examined by reverse transcriptase-polymerase chain reaction assay Contrast CT scans are conducted at baseline day 2 of course 1 and week 8 to assess tumor perfusion
After the completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 44 patients will be accrued for this study
Primary
Determine the 4-month progression-free survival PFS of patients with low-grade neuroendocrine tumors treated with AMG 706 and octreotide acetate
Secondary
Determine the response rate and overall survival of patients treated with these drugs
Determine the toxicity and tolerability of AMG 706 in these patients
Determine the effect of AMG 706 on tumor perfusion by functional computerized tomography CT scan
Determine the effect of AMG 706 on tumor markers eg chromogranin A 5-hydroxyindoleacetic acid and gastrin specific for neuroendocrine tumors
Determine the effect of AMG 706 on serum vascular endothelial growth factor VEGF levels
Determine the expression of VEGF VEGF receptor-2 VEGFR-2 chromogranin A human achaete-scute homolog-1 hASH1 and Notch1 markers of neuroendocrine tumors
OUTLINE This is a multicenter study
Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Plasma samples are collected at baseline periodically during study treatment and at 4 weeks after the completion of study treatment Samples are used to determine plasma VEGF levels Gene expression of downstream markers of Raf kinase expression raf MEK and ERK as well as hASH1 and Notch1 are evaluated at baseline Tumor tissue collected at diagnosis or prior surgery is examined by reverse transcriptase-polymerase chain reaction assay Contrast CT scans are conducted at baseline day 2 of course 1 and week 8 to assess tumor perfusion
After the completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 44 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 |
|---|---|---|---|
| ECOG-E4206 | OTHER | None | None |
| U10CA023318 | NIH | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA023318 |