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:6/28/2017)... ... June 28, 2017 , ... Drs. Steven Crandall, Karen Johnson ... in Pittsburgh, PA, and Upper St. Clair, PA, without a referral. The doctors address ... the health of the temporomandibular joint and facial muscles that support it. , ...
(Date:6/28/2017)... ... , ... Eating disorders have the highest mortality rate of any mental illness ... as a direct result from an eating disorder in the U.S. As the rate ... Foundation meets this challenge by offering what has become the leading certification program for ...
(Date:6/28/2017)... ... June 28, 2017 , ... Park Systems , a leader in Atomic ... SEMICONWest attendees and Park customers on July 11, 2017 from 12-2pm at the ... Chairman & CEO of Park Systems, and Prof. Krishna Saraswat , Rickey/Nielsen Professor ...
(Date:6/28/2017)... ... June 28, 2017 , ... Designers Insurance Agency, ... in northern Virginia and DC, is announcing a cooperative charity event in conjunction ... and other disorders that lead to memory impairment. , The Insight Memory Care ...
(Date:6/27/2017)... ... June 27, 2017 , ... DrugDev understands that ... they can trust the sponsor to pay them correctly and on time. As the ... establish payment strategies that encourage sites to work on their studies. , At a ...
Breaking Medicine News(10 mins):
(Date:6/1/2017)... BELL, Pa. , June 1, 2017 ... (PRN) and Veterinarian Recommended Solutions (VRS), and KD Pharma ... investment in Nutriceutical Holdings by KD Pharma Group. KD ... Holdings with the option to acquire the entire company. ... partner in KD. They are committed to growing the ...
(Date:5/30/2017)... AVIV, Israel , May 30, 2017 ... stage pharmaceutical Company specializing in the development of ... will present a company overview at three upcoming ... The 7th Annual LD Micro Invitational: ... Date:                     ...
(Date:5/26/2017)... May 25, 2017  In response to the opioid ... Direct Relief is working with Pfizer to make up ... no cost to community health centers, free and charitable ... "Pfizer has a long-standing commitment to ... ensuring patient safety through educational activities," said Caroline ...
Breaking Medicine Technology: