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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Exploratory Study of Avastin (Bevacizumab) and RAD001 (Everolimus) in Advanced Low or Intermediate Grade Neuroendocrine Carcinoma (AVF3961s) (CRAD001C2481)

Brief 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.

Detailed Summary:

The Study Drugs:

Avastin is designed to prevent the formation of new blood vessels that help cancer cells to grow. RAD001 is designed to block a protein that is important in the growth of cancer cells.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of two treatment groups. During Cycle 1, one group will receive Avastin and the other group will receive RAD001. Each study cycle is 3 weeks long. In Cycle 2 and every cycle after that, participants in both groups will receive both study drugs. There is an equal chance of being assigned to either group.

RAD001 Administration:

RAD001 tablets are taken once a day by mouth, followed by a large glass of water. The tablets are in a blister-pack under aluminum foil. The blisters should only be opened at the time you take the study drug.

You may either take RAD001 on an empty stomach or after a low-fat meal. Some examples of low-fat meals include: cereal with fat-free milk, muffin or bagel with fat-free spread, or fruit salad. You should avoid taking RAD001 after large fatty meals because this will lower the amount of RAD001 your body absorbs. Your dietary habits around the time you take RAD001 should be as consistent as possible throughout the study.

You should take RAD001 at about the same time each day. The study staff will give you a medication diary that you should bring to every study visit. You will be asked to use the diary by writing down the date and time you take RAD001, how many tablets you take, and any side effects you may experience. Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Net Change Relative to Baseline in Tumor Blood Flow [ Time Frame: Baseline to end of Cycle 3 (63 days) ]

Tumor blood flow (ml/min/100gm) determined by functional computed tomography (CT). Functional computed tomography (CT) at baseline, after first and third cycles (21 day cycles). Change (percentage) calculated as tumor blood flow measured at baseline compared to tumor blood flow measurement taken at end of Cycle 1, week 3 (21 days), and again at end of Cycle 3, Week 9 (63 days).


Original Primary Outcome: The goal of this clinical research study is to learn how Avastin and RAD001 may affect the flow of blood to the tumor. [ Time Frame: 3 Years ]

Current Secondary Outcome:

Original Secondary Outcome:

  • To learn if the combination of RAD001 and Avastin can shrink or slow the growth of advanced low or intermediate-grade neuroendocrine carcinoma. [ Time Frame: 3 Years ]
  • The safety of this combination therapy will also be studied. [ Time Frame: 3 Years ]


Information By: M.D. Anderson Cancer Center

Dates:
Date Received: January 22, 2008
Date Started: January 2008
Date Completion:
Last Updated: May 14, 2013
Last Verified: May 2013