Avastin Trials Suspended

aquinis2000 · 02-13-2006, 08:33 AM

Just Heard On The News That Genentech Had To Suspend Trails Of Avastin Due To Sudden Deaths Associated With The Drug. I Googled Some Articles But Don't Know How To Post Them. Maybe Someone Else Can Do It, And Get More Info On It.

RhondaH · 02-13-2006, 08:42 AM

http://www.bloomberg.com/apps/news?p...Q&refer=europe

Rhonda

AlaskaAngel · 02-13-2006, 08:51 AM

http://www.localnewsleader.com/olber...news&id=142027

The Phase III AVANT trial is designed to see how patients fare when given either conventional chemotherapy drugs or an Avastin-based combination. ...

...The temporary suspension of the study was called for by the trial‘s safety monitoring board following four sudden deaths in one of the three study arms, which involved patients taking Avastin plus the chemotherapy treatment XELOX, comprising Roche‘s Xeloda and oxaliplatin.

Three of the deaths involved younger patients, adding to safety worries.

Excluding deaths due to recurrent colon cancer, the overall death rate in the trial -- which has recruited around 2,000 patients since December 2004 -- was 0.6 percent, or four cases, in the first arm of the study involving patients given chemotherapy known as FOLFOX-4.

The death rate was 0.4 percent, or three cases, in the FOLFOX-4 plus Avastin arm but was 1 percent, or seven cases, in the XELOX plus Avastin arm. The study‘s principal investigator, Professor Aimery de Gramont, said the decision to halt recruitment was necessary, because the threshold for concern was particularly low in patients who have had surgery. But he said he remained hopeful that Avastin would yet show benefits in the post-surgery setting, just as it has done among colon cancer patients with metastatic disease, in which tumors have spread around the body.

al from Canada · 02-13-2006, 03:44 PM

I feel this decision was made out of pananoia and benefits no one. Why would they shut down a trial where the adverse effects were probably lower than that of herceptin?? This goes back to discussions we have recently had on this site about FDA regs, approvals and trial protocals.

Why would they shut-down a program where the prognosis was dismal to start with? Are they protecting us from an untimely yet predictable death?

B.B.B. (Bullshit boggels brains).....
Al