NCT00398320

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Pamela L. Kunz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Capecitabine	850 mg/m2 by mouth twice a day for days 1-14 oa a 21 day cycle
DRUG	Oxaliplatin	130 mg/m2 intravenously on day 1 of a 21 day cycle
DRUG	Bevacizumab	7.5mg/kg Intravenous on day 1 of a 21 day cycle

Timeline

• Start date: 2006-11-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2006-11-10
• Last updated: 2017-03-01
• Results posted: 2013-12-10

Locations

1 site across 1 country: United States