Navigation Links
Phase 3 trial finds no benefit from atrasentan added to chemo for advanced prostate cancer
Date:4/21/2011

ANN ARBOR, MICH. -- A Data and Safety Monitoring Committee (DSMC) has determined that patients in a phase III clinical trial given atrasentan in addition to a standard chemotherapy regimen for advanced prostate cancer did not have longer survival or longer progression-free survival than patients on the same chemotherapy regimen who got a placebo rather than atrasentan.

Almost 1,000 patients who had advanced, hormone-refractory prostate cancer were given up to 36 weeks of chemotherapy with docetaxel and prednisone. These patients were randomized so that one half got an additional pill with a dose of atrasentan while the other half got a placebo pill. Patients who completed their chemotherapy and showed no progression of the disease were given the option of continuing the additional blinded pill (atrasentan or placebo).

The study's DSMC evaluated a planned interim analysis of trial data and determined the evidence indicating no benefit from the drug was strong enough to close the study early rather than waiting another 18 months as was originally planned. The DSMC did not find evidence that the drug was harming patients.

New patient enrollment to the study stopped in April 2010 and few patients continue to take the study pill. Patients still taking study medication should speak to their doctor about stopping safely and what to do with their remaining pills. Treatment assignment is being unblinded, so patients can learn from their study doctor whether they took atrasentan or a placebo.

The study ("S0421: Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer") was supported by the National Cancer Institute (NCI) and was conducted by SWOG (formerly the Southwest Oncology Group) with the participation of several other NCI cooperative groups.

Atrasentan for the trial was provided under an agreement with Abbott Laboratories and was distributed by the Department of Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy Coordinating Center.


'/>"/>

Contact: Frank DeSanto
fdesanto@umich.edu
734-998-0114
University of Michigan Health System
Source:Eurekalert

Related medicine news :

1. NHGRI charts course for the next phase of genomics research
2. Phase III efficacy data on bevacizumab plus chemotherapy in early breast cancer to be presented
3. Euthymics presents phase II data for EB-1010 in major depression at ACNP annual meeting
4. Phase I trial indicates ponatinib may thwart most resistant CML
5. Assessing positive outcomes of phase III trials
6. Professor Zvi Ram presents phase III recurrent glioblastoma survival and quality of life data from the first pivotal study of the NovoTTF-100A at 15th Annual Society for Neuro-Oncology Scientific Meeting
7. Nutrition rating enhancing front-of-package nutrition rating systems and symbols: Phase 1
8. New Phase II study shows first-line promise of lung cancer drug PF-299
9. Pazopanib shows promise in Phase II trial for relapsed/refractory urothelial cancer
10. Phase III study shows everolimus delays tumor progression in hard-to-treat neuroendocrine tumors
11. Front-of-package symbols and systems: IOM phase 1 report
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... Aliso Viejo, California (PRWEB) , ... June 26, 2016 , ... ... for Final Cut Pro X. , "Film editors can give their videos a whole ... artistically," said Christina Austin - CEO of Pixel Film Studios. , ProSlice Levels ...
(Date:6/26/2016)... Orion, Clarkston, Michigan (PRWEB) , ... June 26, ... ... with respect to fertility once they have been diagnosed with endometriosis. These women ... intercourse but they also require a comprehensive approach that can help for preservation ...
(Date:6/25/2016)... ... , ... The temporary closing of Bruton Memorial Library on June 21 due to a possible ... often overlooked aspect of head lice: the parasite’s ability to live away from a human ... but a necessary one in the event that lice have simply gotten out of control. ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern ... Laude and his M.D from the David Geffen School of Medicine at UCLA. He ... Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program ...
(Date:6/25/2016)... ... , ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter ... bar too high can result in disappointment, perhaps even self-loathing. However, those who set ... , Research from PsychTests.com reveals that behind the tendency to set low ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 24, 2016  Collagen Matrix, Inc., ("Collagen Matrix") ... manufacturing of collagen and mineral based medical devices ... Bill Messer has joined the company ... leverage the growing portfolio of oral surgery, neurosurgery, ... Bill joins the Collagen Matrix executive team as ...
(Date:6/24/2016)... , June 24, 2016   Bay ... Rehabilitation Network,s Dean Center for Tick Borne ... Medicine and Rehabilitation, MIT Hacking Medicine, University of ... Innovation, today announced the five finalists of ... Lyme disease.  More than 100 scientists, clinicians, researchers, ...
(Date:6/24/2016)... , June 24, 2016 ... of the "Structural Electronics 2015-2025: Applications, Technologies, ... In-Mold Electronics, Smart Skin, ... Photovoltaics Structural electronics involves electronic ... load-bearing, protective structures, replacing dumb structures such as ...
Breaking Medicine Technology: