Conditions: Neuroendocrine Tumors
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: no

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

Arms:
arm 1: None

Interventions: intervention 1: Capecitabine intervention 2: Oxaliplatin intervention 3: Bevacizumab
Intervention descriptions: intervention 1: 850 mg/m2 by mouth twice a day for days 1-14 oa a 21 day cycle intervention 2: 130 mg/m2 intravenously on day 1 of a 21 day cycle intervention 3: 7.5mg/kg Intravenous on day 1 of a 21 day cycle

Protocol document: