herceptin & mcc-dm1 criteria question

Pam P · 05-10-2008, 08:25 PM

I tried to qualify for this trial, but am told I can't because I don't have 'measurable disease'. I have bone mets and am told that they don't qualify as measurable even though they show up on pet & ct scans. I looked at the info on clinicaltials.gov on the study and I don't see any mention of 'measurable disease', just mbc, her2+, etc.

I really want to get into this trial -- anyone have any clarification on this that I could use to appeal getting in?

If not I'm due to start taxol & avastin next week & am dreading that regime.

Thanks. Pam

Julie2 · 05-11-2008, 10:39 AM

Pam,

Barbara H is on this trial and with bone mets only she was able to enter the trial.

Julie

chrisy · 05-11-2008, 11:07 AM

I reread the NCI criteria for this trial, and in the description it does refer to "efficacy measurable" trial subjects. That doesn't answer the question of why bone mets only would not be measurable disease - although it is true that bone mets sometimes "look worse" on scans initially even when a treatment is working. Maybe that has something to do with it. Maybe Barbara H can provide more insight.

Have you challenged your doctor on why this would not be "measurable"?

Good luck.
Chris

Pam P · 05-11-2008, 05:34 PM

Chris & Barbara --
My onc. wanted me to get on the trial, but the group/person that says whether they'll accept (sorry I should know the term for that but can't think of it) said no bone mets when asked if I could get in. My onc.'s office has a good research nurse that pursued it. This is the phase 11 trial that I applied for. I wish I could find a compelling argument to appeal. I'm counting downt they days until I start taxol/avastin on Wed.