Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT00398320
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2006-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase II Capecitabine, Oxaliplatin & Bevacizumab for Metastatic / Unresectable Neuroendocrine Tumors
Sponsor:
Pamela L. Kunz
Organization:
Study Overview
Official Title:
A Phase II Study of Capecitabine, Oxaliplatin and Bevacizumab for Metastatic or Unresectable Neuroendocrine Tumors
Status:
COMPLETED
Status Verified Date:
2017-01
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:
Given the lack of other viable treatment options for metastatic neuroendocrine tumors, contrasted with our positive anecdotal experience, and the relative tolerability of the treatment regimen for colorectal cancer patients, we propose a single-institution phase II trial investigating the efficacy of capecitabine, oxaliplatin and bevacizumab for patients with metastatic neuroendocrine tumors.
Detailed Description:
PRIMARY
1. Determine an estimation of median time to progression (TTP) for patients treated with bevacizumab in combination with capecitabine and oxaliplatin
2. Assess the toxicities associated with this regimen
SECONDARY
1. Determine objective response rate (RR) for patients treated with this regimen
2. Conduct exploratory analyses of efficacy according to degree of tumor differentiation and primary location
3. Determine utility of biochemical markers as a surrogate endpoint for tumor response
1. Determine an estimation of median time to progression (TTP) for patients treated with bevacizumab in combination with capecitabine and oxaliplatin
2. Assess the toxicities associated with this regimen
SECONDARY
1. Determine objective response rate (RR) for patients treated with this regimen
2. Conduct exploratory analyses of efficacy according to degree of tumor differentiation and primary location
3. Determine utility of biochemical markers as a surrogate endpoint for tumor response
Study Oversight
Has Oversight DMC:
True
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?: