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Phase II Capecitabine, Oxaliplatin & Bevacizumab for Metastatic / Unresectable Neuroendocrine Tumors

Neuroendocrine Tumors Clinical Trial

Official title:
A Phase II Study of Capecitabine, Oxaliplatin and Bevacizumab for Metastatic or Unresectable Neuroendocrine Tumors

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00398320
Study type Interventional
Source Stanford University
Contact
Status Completed
Phase Phase 2
Start date November 2006
Completion date October 2012
View Details
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