Clinical trials

Bevacizumab is the generic name for Avastin. It's been used and is approved by the FDA for colorectal and kidney (or liver??) cancer for the last few years. Also has been used for metastatic breast cancer in combination with capacetabine (xeloda) and with paclitaxel (taxol). It was recently conditionally approved by the FDA for use with paclitaxel - but there may be some trials that are continuing to use bevacizumab with capacetabine.



I took avastin with nab-paclitaxel (Abraxane - a non-protein bound form of taxol and one that doesn't require pre-meds with a steroid) for almost 11 months. The worst SE was bloody nose and runny nose and eyes. I also got high blood pressure after about six months, but medication seemed to fix that until I stopped. Then blood pressure returned to normal.



Who's conducting the clinical trial? What phase is it in? How many are in the study? Is it single arm or double blind? What have the results been to date? How will results be measured and how will you be followed? Why would your particular cancer be a good match for these drugs? All good questions to ask.



Have you gotten all your path results back yet?



Good luck. Hope I didn't confuse you more, but I went through all this a while back before deciding to participate in a clinical trial. I wish I'd asked all the questions I suggested to you!

Annie,

Here are a couple of websites where you can look up clinical trials. I think there may be some redundancy.

http://clinicaltrials.gov/

http://www.cancer.gov/clinicaltrials

I checked under "capecitabine gemcitabine bevacizumab" as keywords and found a couple for BC that are currently in the recruiting phase.

Ask your doc to let you have a copy of the "informed consent" for the study, so you can take it home and read it before you have to make a decision.

Oh, and get some sleep tonight!

otter 

Annie,

I did Gemzar, Avastin with carboplatinum over a year ago outside of a trial.  This combo "was" usually for ladies with mets.(mine was skin)  Many of us have used this combo in the last year.  Have you been on the mets site to see what they say?  I did this for four months (weekly after 4 mths of ACT) and did not loose my hair and went to work very tired but I went eveyday. This combo worked for me.  Only long therm side effect was high blood pressure that went away after about four months.

All chemo's fine print will scare you to death.

Living in hope.

Flalady

We just had the head of the clinical trials at the hospital at the last support meeting and he said that in any trials, everyone gets the standard of treatment but some get the medicine that they are testing added into the mix. For example standard treatment is A and B, and they want to test C, some will get A+B some will get A+B+C. No one goes without the standard treatment. In most cases you don't know if you are getting the new stuff until after the trial has completed.

Sheila

I was just trying to state that you would not be without any treatment, some would get the medicine that is on trial.

There was a trial that they are doing locally with DCIS patients more than 2 yrs out from dx and having 3 or more hot flushes per day. I do not qualify for the trial because I am less than 1 yr from dx and I am still premenopausal. though I do have the hot flushes.

Sheila

Hi Everyone,

I am on a clinical trial.  I don't have mets but do have pos nodes.  My treat was going to be 4 dose dense A/C each 2 weeks then 12 weekly taxols.  I am also taking avastin, well maybe.  the way the trial is 20% get saline, 80% avastin....at the last treatment you get unblinded and if you are receiving the avastin then you find out if you are in the arm that ends with treatment or you go on for another 10 treatments of avastin by its self, every 3 weeks.  My side effects make me think I am getting the real stuff, nose bleeds, hoarse voice, ect.  Nothing bad at all, especially compared to A/C.  My doctor said I'm like the poster child for this, since I'm not stage 4.  I figured I'm recieving what I was going to get and maybe this will give me an edge to avoid reoccurrence.

One other thing, my mom died in july from colon cancer and it was very advanced when it was found....she was inoperable and only had a few months at best....she lived 3 years, three very good years and I believe with out a doubt avastin played a huge part in that. 

Teresa

You are all a particularly strong group of ladies and I applaud you. It may well be that the knowledge gleaned from triple negative disease leads us out of the years in the desert.



Heather, I know you are reading diligently and considering the words, dissecting the documents, and talking with experts and family.



Remember too, you can always come off of a clinical trial at any time. No questions asked, no intimidation should be given.



Amazing that Avastin and small molecule therapy is now filtering down to early stage bc trials. Think how far we have come since just 2001! And then add in Oncotype Dx and Mammoprint. And CYP2D6 and other enzyme analysis.



I mourn it has not come fast enough though for our Angels.

Tender

Hi Annie,

I think I am in the same trial as Teresa w/the dd A/c, and 12 Taxol at the same time receiving Avastin.  I have had the same se's, bloody nose (less than 5min), hoarse voice, running eyes, nose.  not so bad.  The one thing about the Phase III trial drugs are they have gone thru 2 other phases.  You do have EXTRA tests, echocardiogram, ekg.  But you also get the standard treatment.  Science wouldn't be where we are without people participating in these trials.  I might be in the placebo (20%) and if so, I just added some extra time at the center.  If I am inthe 80% w/drug and it works then science has made a leap forward (hopefully).  To me, it was a hard decision until I spoke to an elderly lady who had double masect back in 80, no chemo/rads. She ended up w/liver cancer and had tumor removed at sloan kettering and put on a trial drug which made her sick. We didn't think she would make it thru the year. she looked terrible.  She went off that drug onto Avastin and called me when she found out about my dx and she is doing great. Her body accepted the avastin and she had a small tumor come back before she went on avastin. The tumor has shrunk and she is going back to driving which hasn't done in years, BTW she is 73 yrs old.  Just keeping the faith!  Good luck on your decision because you are the one that needs to make that choice.

Carolyn

Annie,

I have been following your posts from your first and I just wanted to say I am so glad you are finally home and that you have a diagnosis and can finally move forward. I know you have been through a lot and I commend your strength.

Kim

I haven't been here for a while.  I have finished up w/my 4th treatment of Taxol w/Avastin.  8 more taxols to go...Yippee!  I will find out on April 14th if I was a placebo or I was getting the real drug.  I have only had 1 problem w/taxol and it was the time when I did not take the steroids the night before.  This 4th session did make me very tired. After receiving treatment, I had to go home to nap.  It might of been that I was up at 4:30 in the morning on the treadmill trying to run 3 miles...I hope all is well with my sister chemo buddies.  Keep plugging away.  We will get thru this before we know it...BTW, Monday is St. Pattys day and chemo day...Got a green wig to shine when I go in or at least to get a good laugh! I would also like to share a card I rec'd from my sil:  No one said it would be easy to lose your hair. But knowing you, you'll find a way to turn this situation around and use it as a badge of honor, a sign to the world that your treatments are working. And when this is all behind you and your hair grows back, you'll be able to say w/assurance that every day is a good hair day.

Hugs to all,

Carolyn