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Avastin (Bevacizumab) and RAD001 (Everolimus) in Advanced Low or Intermediate Grade Neuroendocrine Carcinoma

NCT00607113 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2013-07-18

Study results available
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Summary

Primary Objectives:

* To determine the effect of Avastin on tumor blood flow as determined by functional computed tomography (CT) in patients with low or intermediate grade neuroendocrine carcinoma.
* To determine the effect of RAD001 on tumor blood flow as determined by functional CT in patients with low or intermediate grade neuroendocrine carcinoma.
* To determine the effect of adding the second agent (Avastin or RAD001) to the first agent (RAD001 or Avastin) on tumor blood flow as determined by functional CT

Secondary Objectives:

* To determine the clinical activity (objective response rate and progression free survival duration) of Avastin and RAD001 in patients with low or intermediate grade neuroendocrine carcinoma.
* To determine the biochemical response rate of Avastin and RAD001 in patients with low or intermediate grade neuroendocrine carcinoma.
* To determine the safety and tolerability of Avastin and RAD001 in patients with low or intermediate grade neuroendocrine carcinoma.

Conditions

  • Neuroendocrine Carcinoma

Interventions

DRUG

Avastin

15 mg/kg By Vein Over 90 Minutes Every 21 Days

DRUG

RAD001

10 mg By Mouth Daily For 21 Days

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • James Yao, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00607113 on ClinicalTrials.gov