Frontiers

Bench to Bedside 

Tags:

OSU-09067 – Phase II Trial of Temsirolimus and Bevacizumab in Patients with Carcinoid Cancer

HYPOTHESIS: Temsirolimus (CCI-779) and bevacizumab (Avastin) combined will induce stable disease in patients with carcinoid cancer.

RATIONALE: Carcinoid tumors arise from diffuse neuroendocrine cells, most often those in the GI tract, the pulmonary bronchi and pancreas. GI sites are primarily the stomach, ileum and appendix. The tumors may be benign or malignant and cause pain, obstruction and bleeding. Carcinoid tumors may be endocrinologically active, producing a variety of hormones, which may cause carcinoid syndrome. The syndrome is often marked by striking skin color changes, abdominal cramps and diarrhea, right-side endocardial fibrosis and increased excretion of the serotonin metabolite 5-HIAA.

Although curative resection of carcinoid tumors is possible, no effective chemotherapeutic regimen is available for systemic spread, but targeted agents hold promise. VEGF is a critical proangiogenic factor in these hypervascular tumors. In one study of 50 cases of human gastrointestinal neuroendocrine tumors, VEGF expression was associated with poor progression-free survival. Neutralization of VEGF by bevacizumab has been shown to inhibit the VEGF-induced proliferation of human endothelial cells in vitro, and decrease microvessel density and interstitial pressure in tumor xenografts in vivo.

In patients, preliminary results from a neoadjuvant trial in rectal cancer demonstrated a decrease in blood perfusion/permeability and interstitial fluid pressure in tumors after one dose of bevacizumab. Bevacizumab has shown promising antitumor activity in preclinical and clinical studies of patients with carcinoid tumors.

Temsirolimus is a cytostatic cell-cycle inhibitor with antitumor properties. The agent specifically inhibits the mammalian target of rapamycin (mTOR), a Ser/Thr kinase involved in the initiation of mRNA translation. Temsirolimus inhibits the growth of a histologically diverse range of tumor cells, with the greatest sensitivity shown by cells derived from central nervous system cancers, leukemia (T‑cell), breast cancer, prostate cancer and melanoma. Key features of this agent include its tolerability, unique mechanism of action, ability to arrest cells in the G1 phase, and ability to induce apoptosis.

A phase II study of single agent temsirolimus and a phase II study of bevacizumab plus octreotide in patients with advanced progressive neuroendocrine carcinoma also showed moderate antitumor activity. This study evaluates bevacizumab and temsirolimus as combined therapy in patients with metastatic carcinoid tumors.

Note: OSU-09067 is part of NCI Protocol #8233, a single study that examines the same therapy in five diseases using five parallel phase II clinical trials.

The overall purpose of NCI # 8233 is to evaluate the safety and effectiveness of temsirolimus and bevacizumab in patients with endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer. Each of the two drugs individually has shown some benefit in each of these malignancies.

NCI # 8233 is supported by the NCI Cancer Trials Support Unit, and participation is restricted to centers with an NCI-supported phase II contract. The study chair is Charles Erlichman, MD, professor and chairman of Oncology at Mayo Clinic.

http://clinicaltrials.gov/ct2/show/NCT01010126?term=temsirolimus+neuroendocrine&rank=6

AT A GLANCE
Clinical trial OSU-09067

PI: Manisha Shah, MD, director, Neuroendocrine Tumor Clinic Program

Phone: 614-293-8529

Email: Manisha.Shah@osumc.edu

Eligibility: Histologically/cytologically confirmed carcinoid (neuroendocrine) cancer that is locally advanced, recurrent, metastatic or progressing; Age 18 years or older; Must have measurable disease; Radiation therapy must be completed four weeks or more prior to registration if applicable; ECOG 0-1; Must have tissue available from the primary tumor or metastases for tumor studies.

 

 
11-Oct-10
64  Comments  |  Trackback Url  | 0  Link to this post

Bookmark this post with:        
 

Links to this post

Comments


usammdeals  commented on  Tuesday, October 07, 2014  2:56 AM 
Experiential is mostly about valuing any experiences you undoubtedly have about what that you're told it's best to being engaging in by some other individual. We're many different, we most of enjoy different things and some of our have to reflect the fact that.


Shearlock Holmes coat  commented on  Friday, October 31, 2014  6:48 AM 
Practical overview about the topic! I am delighted to read your putting stuff to distribute others.


Free PDF Ebooks  commented on  Sunday, November 09, 2014  5:25 AM 
Eu teria que verificar com você aqui. O que não é algo que costumo fazer! Eu gosto de ler um post que vai fazer as pessoas pensarem. Além disso, graças por me permitir comentar!


psd to html  commented on  Wednesday, November 12, 2014  12:47 AM 
O que não é algo que costumo fazer! Eu gosto de ler um post que vai fazer as pessoas


cookware reviews  commented on  Sunday, November 16, 2014  5:27 AM 
Linking is very useful thing.you have really helped lots of people who visit blog and provide them usefull information...


Green Smart Living  commented on  Sunday, November 16, 2014  6:49 AM 
Gsite that anine bing I think it would be a good asset. This is the kind of content that will give clearance to this issue.


diaita  commented on  Monday, November 17, 2014  4:57 AM 
Many company exhibitions, like contractors’ businesses, experienced significantly during the excellent economic slowdown of the last few decades. - <a href='http://c1.grigoridiaita.gr/' target='_blank'>diaita</a>


Free PDF Ebooks  commented on  Tuesday, November 18, 2014  1:18 AM 
I think it would be a good asset. This is the kind of content that will give clearance to this issue.


pharmacy assistant jobs  commented on  Tuesday, November 18, 2014  4:54 AM 
I think it would be a good asset. This is the kind of content that will give clearance to this issue.


brooklyn preschools  commented on  Wednesday, November 19, 2014  5:18 AM 
I think it would be a good asset. This is the kind of content that will give clearance to this issue. a


texas rehab centers   commented on  Thursday, November 20, 2014  12:14 AM 
about the topic! I am delighted to read your putting stuff to distribute others.


rehabs in texas   commented on  Thursday, November 20, 2014  12:17 AM 
contest for one of the finest sites online. I am berita-idblogs going to recommend this website!


West Palm Beach Escorts  commented on  Thursday, November 20, 2014  6:05 AM 
contest for one of the finest sites online. I am berita-idblogs going to recommend this website!


home remedies to help with allergies  commented on  Saturday, November 22, 2014  6:23 AM 
contest for one of the finest sites online. I am berita-idblogs going to recommend this website!


Forex Trading In US   commented on  Sunday, November 23, 2014  5:18 AM 
No seas obstinado, conseguir más allá de cualquier insatisfacción roer que podrían envenenar a sus esfuerzos, mirar más allá de los detalles desagradables y mantener los ojos en el horizonte.


Alan Robertson  commented on  Monday, November 24, 2014  6:05 AM 
I am berita-idblogs going to recommend this website!


social marketing  commented on  Tuesday, November 25, 2014  12:24 AM 
Guar Fast Hydration Polymers used in Gas Oil Fields fracturing Industry in the world ....


punching bags  commented on  Thursday, November 27, 2014  2:18 AM 
Hydration Polymers used in Gas Oil Fields fracturing Industry in the world .


what are feminized seeds  commented on  Saturday, November 29, 2014  12:54 AM 
used in Gas Oil Fields fracturing Industry in the world .


bench seat  commented on  Saturday, November 29, 2014  5:44 AM 
Fields fracturing Industry in the world .


phil and teds  commented on  Sunday, November 30, 2014  2:29 AM 
Industry in the world .


ny divorce law  commented on  Sunday, November 30, 2014  7:06 AM 
going to recommend this website!


where to get divorce papers  commented on  Tuesday, December 02, 2014  2:32 AM 
Polymers used in Gas Oil Fields fracturing Industry in the world ...


manual social bookmark  commented on  Tuesday, December 02, 2014  4:57 AM 
mostly about valuing any experiences you undoubtedly have about what that you're told it's best to being engaging


Low OBL deal for Your Website Ranking  commented on  Wednesday, December 03, 2014  4:48 AM 
Tuesday, December 02, 2014 4:58 AM
mostly about valuing any experiences you undoubtedly have about what that you're told it's best to being engaging


wicker hamper with lid  commented on  Thursday, December 04, 2014  2:15 AM 
experiences you undoubtedly have about what that you're told it's best to being engaging


implants dental  commented on  Saturday, December 06, 2014  12:51 AM 
you undoubtedly have about what that you're told it's best to being engaging


UNIQUE DOMAINS  commented on  Saturday, December 06, 2014  5:21 AM 
mostly about valuing any experiences you undoubtedly have about what that you're told it's best to being engaging


PDF Links.twelve  commented on  Sunday, December 07, 2014  1:18 AM 
experiences you undoubtedly have about what that you're told it's best to being engaging


Learn Forex  commented on  Sunday, December 07, 2014  2:52 AM 
mostly about valuing any experiences you undoubtedly have about what that you're told it's best to being engaging


on demand electric water heater  commented on  Monday, December 08, 2014  2:14 AM 
right-side endocardial fibrosis and increased excretion of the serotonin metabolite 5-HIAA.


handstand girl  commented on  Monday, December 08, 2014  2:29 AM 
going to recommend this website!


portable storage units moving  commented on  Monday, December 08, 2014  4:29 AM 
This is a truly good site post. Not too many people would actually, the way you just did. I am really impressed that there is so much information about this subject that have been uncovered and you’ve done your best, with so much class. If wanted to know more about green smoke reviews, than by all means come in and check our stuff.


storage container trailer  commented on  Monday, December 08, 2014  7:35 AM 
by all means come in and check our stuff.


defense contractor jobs  commented on  Monday, December 08, 2014  9:06 AM 
by all means come in and check our stuff.


engagement and wedding rings  commented on  Tuesday, December 09, 2014  1:54 AM 
come in and check our stuff.


document destruction service  commented on  Tuesday, December 09, 2014  3:48 AM 
This is a truly good site post. Not too many people would actually, the way you just did. I am really impressed that there is so much information about this subject that have been uncovered and you’ve done your best, with so much class.


heavy equipment trader  commented on  Tuesday, December 09, 2014  5:22 AM 
is so much information about this subject that have been uncovered and you’ve done your best, with so much class.


attorney search san diego  commented on  Wednesday, December 10, 2014  8:49 AM 
This is a truly good site post. Not too many people would actually, the way you just did. I am really impressed that there is so much information about this subject that have been uncovered and you’ve done your best, with so much class. If wanted to know more about green smoke reviews, than by all means come in and check our stuff.


Forex Education Online  commented on  Thursday, December 11, 2014  12:10 AM 
people would actually, the way you just did. I am really impressed that there is so much information about this subject that have been uncovered and you’ve done your best, with so much class.


pen drives  commented on  Thursday, December 11, 2014  3:45 AM 
At the 5:34 point in the video/lecture the year 1500 is mentioned as a divergence point for GDP per capita. It’s further mentioned that the divergence point of GDP per capita is associated with the industrial revolution.


bbq caterers  commented on  Thursday, December 11, 2014  4:23 AM 
divergence point of GDP per capita is associated with the industrial revolution.


Frank Download free Full HD  commented on  Friday, December 12, 2014  12:34 PM 
GDP per capita is associated with the industrial revolution.


get free website traffic  commented on  Saturday, December 13, 2014  5:32 AM 
right-side endocardial fibrosis and increased excretion of the serotonin metabolite 5-HIAA.


how to get votes for contest  commented on  Saturday, December 13, 2014  10:53 AM 
The version traffic and simulated sections will cover all new portions with the help of fixed functions.


free vpn server  commented on  Sunday, December 14, 2014  12:40 AM 
The version traffic and simulated sections will cover all new portions with the help of fixed functions.


nutrisystem d  commented on  Sunday, December 14, 2014  3:53 AM 
It's genuinely very difficult in this active life to listen news
on Television, so I simply use web for that purpose, and get the most recent news.


best natural supplements  commented on  Sunday, December 14, 2014  6:34 AM 
I think a country like Nigeria is a good example for the so-called resource curse..


wordpress themes  commented on  Sunday, December 14, 2014  10:02 AM 
I think a country like Nigeria is a good example for the so-called resource curse..


food allergy  commented on  Monday, December 15, 2014  2:09 AM 
Nigeria is a good example for the so-called resource curse..


lupus symptoms  commented on  Monday, December 15, 2014  4:41 AM 
Despite the hard times that the world as a whole is experiencing at the moment, there is still a great deal of traveling going on. Not so long ago, traveling and especially long distance traveling was the privilege of the business person and the rich in general.


lupus symptoms  commented on  Monday, December 15, 2014  4:42 AM 
Despite the hard times that the world as a whole is experiencing at the moment, there is still a great deal of traveling going on. Not so long ago, traveling and especially long distance traveling was the privilege of the business person and the rich in general.


email marketing service providers  commented on  Monday, December 15, 2014  5:56 AM 
long distance traveling was the privilege of the business person and the rich in general.


assicurazione auto  commented on  Monday, December 15, 2014  6:02 AM 
long distance traveling was the privilege of the business person and the rich in general.


motorcycle led driving lights  commented on  Tuesday, December 16, 2014  2:54 AM 
traveling was the privilege of the business person and the rich in general.


Going Here  commented on  Tuesday, December 16, 2014  5:02 AM 
The version traffic and simulated sections will cover all new portions with the help of fixed functions.


saticoy self storage  commented on  Tuesday, December 16, 2014  7:40 AM 
The version traffic and simulated sections will cover all new portions with the help of fixed functions.


buy a copier  commented on  Wednesday, December 17, 2014  2:38 AM 
traffic and simulated sections will cover all new portions with the help of fixed functions.


diet for type 2 diabetes  commented on  Wednesday, December 17, 2014  2:16 PM 
These are the summer choices to the big rules with the entry passage on the simple clean shakes.


national moving companies  commented on  Thursday, December 18, 2014  1:19 AM 
The lavish celebrations of the people who are eager in generating free roblox robux are now open,so please click on the given link


joint pain remedy  commented on  Thursday, December 18, 2014  2:08 AM 
you've kept program it you, the hospital's details system usually takes weeks and also months to receive it back.


material handling  commented on  Thursday, December 18, 2014  4:05 AM 
you've kept program it you, the hospital's details system usually takes weeks and also months to receive it back.


equipment rental greensboro nc  commented on  Thursday, December 18, 2014  5:18 AM 
You wrote something that people could understand and made the subject intriguing for everyone.


remodeling services  commented on  Thursday, December 18, 2014  5:24 AM 
A random selection of bakeware too. But there’s one thing I’ve been testing out that will help to make these assorted pieces flow together a little more uniformly (and give a bit of theme to the dinner). Thank you, paint markers for making custom dinnerware such a phenomenal (and easy DIY) thing...

Name *:
URL:
Email:
Comments:

CAPTCHA Image Validation