Clinical Trial E5103

Options
1…4445474950…59

Comments

  • kfinnigan
    kfinnigan Member Posts: 1,729
    edited October 2009

    I've had so many of those tests, I just went online and looked at a graph of just those numbers, and mine went up and down like a yo yo through the whole chemo process.  Last ones were Total protein <.6 and creatinine was 49, which was right about pre-chemo numbers.  

    · Share on FacebookShare on Twitter
  • iharris
    iharris Member Posts: 5
    edited October 2009

    I have been reading these posts since I was diagnosed.  I am finally joining in.  I was in this avastin double blinded trial . I started in Oct 08 and was unblinded in Feb 09.  I thought for sure that I was getting it. During my chemo ,the week before I was told which group I was in, we asked my nurse to guess which group I was in, she shocked me when she said placebo,because I had  never even considered it. I asked her what made her think that and she said that everyones blood pressure was very high who was on it.  Of course she was right.  I was also in the placebo.  I was devastated.   There were only 3 of us in this trial at the time at my hospital.  Today, there are 9. I have learned that everything happens for a reason.  I,m doing well. Look better than before bc, and I>m moving on.

    · Share on FacebookShare on Twitter
  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    Thank you for sharing dear IHarris. After 3 AC + Avastin/Placebo, I don't have any Avastin specific symptoms and my BP is staying normal before and after infusions. I think I'm on placebo too.

    · Share on FacebookShare on Twitter
  • michellehb
    michellehb Member Posts: 35
    edited October 2009

    My BP was mostly the same, sometimes lower. My only SE's were the nose bleeds. Had some gastro issues, tho not sure if Avastin related. Wish I could give you my Arm C.

    · Share on FacebookShare on Twitter
  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    Michelle..... Thanks for that thought.

    · Share on FacebookShare on Twitter
  • carolynf
    carolynf Member Posts: 262
    edited October 2009

    Hello ladies,

     I haven't posted in a while and was just catching up on the threads.  I was wondering how many of you have received letters in regards to the trial?  I have not received anything in writing and was in Arm C.  I am just curious.  I do have an onc appt in another week and then I can start extending that out to 6 months!  Keep your spirits up...it does get better!

    · Share on FacebookShare on Twitter
  • jenn3
    jenn3 Member Posts: 3,316
    edited October 2009

    I haven't rec'd a letter, but did have to sign a waiver a two weeks ago reconfirming that I wanted to stay in the trial (and was given a copy of the waiver). 

    · Share on FacebookShare on Twitter
  • kfinnigan
    kfinnigan Member Posts: 1,729
    edited October 2009

    I finished the trial Aug. 6th and haven't received a letter.  Just received the letter about the follow up "stalking" haha they will do on me for years to come.

    · Share on FacebookShare on Twitter
  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    I do not know if they would send the enrollment suspended letter to the patients who have completed the treatment. Would they?

    · Share on FacebookShare on Twitter
  • michellehb
    michellehb Member Posts: 35
    edited October 2009

    I never got a letter, nor was I asked to sign a waiver. Go figure.

    · Share on FacebookShare on Twitter
  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    Dear Michelle,

    On 28th September my onco gave me an unsigned typed sheet of paper which had some of the verbiage about the suspension of enrollment. This was not on a letterhead. They did not ask me to sign anything either. I do not believe that that is the correct protocol and I could raise a stink but I have bigger fish to fry.....

    · Share on FacebookShare on Twitter
  • jenn3
    jenn3 Member Posts: 3,316
    edited October 2009

    Unk - You are right, it isn't correct protocol to sign w/o letterhead, the original paperwork I signed did not have letterhead and was returned.  I was asked to resign the same exact paper again this week w/letterhead in order for it to be accepted. 

    Kari - You are so going to be stalked for years to come............................ Just when you think you're done - they'll be back for more...................

    · Share on FacebookShare on Twitter
  • michellehb
    michellehb Member Posts: 35
    edited October 2009

    Onty - Same here. I figured in the grand scheme, not a big concern. And not in my advantage to sign, so why press it?  The lack of thoroughness bugs me, though. I often feel like they are too busy to spend time with me.

    · Share on FacebookShare on Twitter
  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    No I bet they will bring the paper for me to sign after I am done...

    I am guessing the official letter is a bit more ominous and they don't want to show that to patients for fear that the patients would run away :-)

    · Share on FacebookShare on Twitter
  • carolynf
    carolynf Member Posts: 262
    edited October 2009

    I guess I shouldn't worry about it.  It will be 1 yr on Nov since I finished my final Avastin.  I have not rec'd anything besides going to my onc. for my appts.  I've only had blood work done since then, no follow up EKG/Echo.  I guess if there were no issues while on the drug then they don't worry about things after?

    · Share on FacebookShare on Twitter
  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited October 2009

    Technically they should write to the patients who have completed treatment to go in for a heart checkup so that any other cases of CHF can be identified early but that would be not good for the big pharma, would it?

    · Share on FacebookShare on Twitter
  • sftfemme65
    sftfemme65 Member Posts: 790
    edited October 2009

    Carolyn,

    I will be one year out from talking Avastin in November too.  I haven't recieved a letter but I did call the study nurse when I heard all this and she said the onc will tell me all about it at my next appt.  I see him on November 23rd.

    Teresa

    · Share on FacebookShare on Twitter
  • brena
    brena Member Posts: 458
    edited October 2009

    Hi ladies,

    Just a recap, the letter I received was from the trial coordinator, which was originally written by the E5103 board. It says the trial has been suspended, no new entries into the trial but those in the trial (ongoing or finished) can drop out of the trial if desired. The form required that I indicate what I wanted to do, the form provided me the 6 out of 200 woman had CHF was the reason for the trial suspension. I believe the information was sent to your clinical trial coordinator who then relays the information to the patients, at least that is how mine was communicated. Everyone in the trial should receive a letter, they even asked for my PCP to send him the same information.

    The risk is no greater now than when you were told of the ricks originally you now have data to support the stated risk, Avastin and Adriamycin are both toxic drugs to the hear (don't think you can get more potent drugs to the heart.) The trial requires a MUGA be performed when you start the trial and when you finish, if the initial test is below 50% you are not suppose to be accepted into the trial. If determined medically needed you can get additional MUGA scans at anytime. If you have any medical concerns or questions ask your Onc or PCP. I remember I had heart palpitations one time while taking Adriamycin, scary but did stop and Onc did monitor several time with an ECG. Palpitations never happened again. My MUGA was performed 3 times and scores went from 56,57, 62% so you see it can imporove not always negative but nice to know where your at for future reference.

    Don't want to see anyone get paranoid but never let your guard down, not even in 10 or 20 years when we most likely will have put this behind us (thinking positive.) Keep  your records of all tests for future reference so you don't have to play the memory game or rely on a doctor office for maintaining your records. BE YOUR MEDICAL RECORD KEEPER.

    thinking of you ladies quite often and am always reading your messages,

    · Share on FacebookShare on Twitter
  • brena
    brena Member Posts: 458
    edited October 2009

    Carolyn,

    Do the kids know about the cruise? It is almost time for departure. Your next visit is soon drop us a line and let us know how you make out, nice to share with everyone the progress they will make.

    take care,

    · Share on FacebookShare on Twitter
  • brena
    brena Member Posts: 458
    edited October 2009

    iharris,

    Sorry to hear of your devastation of being in the placebo trial, as you already know I also was in the placebo. You caught my attention when you said all things happen for a reason and I feel exactly the same way, we just don't know why. I wish you had found the group sooner as I am sure it would of been nice to have chats on your thoughts. I had always had normal blood pressure but did have quite a few high episodes and nose bleeds while on treatment and being in the placebo group blew my trial nurse and Onc away as they were sure I was getting the Avastin. I was also disappointed but knew the chance when I entered. If you have read earlier posts you will know those woman who received the Avastin went through double hell, so they paid their dues to benefit. How is your follow-up going with your Onc?  do stop in once in a while and give and ear to those still going through the process and let us know how your doing mentally and physically.

    one helluva woman,

    · Share on FacebookShare on Twitter
  • jenn3
    jenn3 Member Posts: 3,316
    edited October 2009

    I had my Taxol w/Avastin - Placebo last Friday and my SE's this week were much much worse, mirrored the 1st Taxol w/Avastin-Placebo ( and similar to AC w/Avastin-Placebo).  My nose/sinuses are bloody & terrible, cactus butt and I have to say my aches and pains were much more intense and lasted all week.  Either I'm on Avastin or it's in my head.  I can't wait to find out if I mentally got myself worked up on the Avastin-Placebo days and my body physically reacted to it or if I really am on Avastin.

    Breana - I also had heart palpitations, but only during the AC portion of chemo, which stopped with the Taxol.  I do worry, but feel like I was warned of all of the SE's to the chemo drugs and the trial drug beforehand and have had several heart scans, EKG and such and everything is normal (for now -don't want to jinx myself).  Honestly, I was more worried about the AC, as the warnings that came with it said it could permamently damage the heart.   Thanks for the information.

    All of the trial information I am receiving is coming through my trial nurse when I go in for visits.  If I'm not mistaken I remember the nurse telling me when I signed up that the people doing the study would not contact me directly, it would all go through the trial nurse @ my facility.  And....I'm okay with that.  But......this may be why letters are not going directly to the patients - the group handling the trials at your facility more than likely have the correspondence.

    Hope everyone has a great Friday............................. with minimal SE's.

    · Share on FacebookShare on Twitter
  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited November 2009

    Dear Jenn,



    It sure sounds like you are on Avastin. I think I maybe on placebo. Other than very slight redness in sputum when I threw up this morning I have not had any Avastin symptoms and I have had 3 treatments now.







    · Share on FacebookShare on Twitter
  • jenn3
    jenn3 Member Posts: 3,316
    edited November 2009

    I'm not sure, but the SE's were much more intense, which is why I'm really curious to see if it's in my head or if it's Avastin.  

    I will say that my muscle aches in general are worse with Taxol - my sister actually thinks it sounds more like nerve pain because I'm also sensitive to touch as well.  Ugh!  I just can't wait for all of this to be over........................

    · Share on FacebookShare on Twitter
  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited November 2009

    Dear Jenn,

    Is it muscle or bone pain?

    · Share on FacebookShare on Twitter
  • jenn3
    jenn3 Member Posts: 3,316
    edited November 2009

    I tend to have (very) sharp pains run through the muscles of my lower back and thighs, mixed with achiness.  Then from my shoulders down my back I am sensitive to touch - such as my sister trying to rub my shoulders - painful, rubbing the scrunchy on me in the shower - painful..... All of this is mixed with muscle stiffness for 3 days starting about 24-48 hours after chemo. 

    · Share on FacebookShare on Twitter
  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited November 2009

    Could it be referred pain from bone pain?

    · Share on FacebookShare on Twitter
  • jenn3
    jenn3 Member Posts: 3,316
    edited November 2009

    I don't know, this is the first time I've had pain and stiffness like this.   When I talk to my onc about it he says that during chemo our bodies are much more sensitive to pain, blah, blah, blah - this is normal and doesn't seem in the least bit surprised.  The pain is very intense the few days after chemo, then begins to get better and of course is all but gone by chemo day (except last week - the pain seemed to linger.....)

    · Share on FacebookShare on Twitter
  • Diane48
    Diane48 Member Posts: 50
    edited November 2009

    Well I go in tomorrow for Taxol #8 out of 12 Yay. I was supost to be unveiled to see if I have been getting a trial drug, avastin but the trial study nurse is off on wed so she will have to contact me on Thursday. I have started getting neuroapthy in my hands and feet but hopefully since I am almost done it will go away.

    My best to all my friends!!

    Diane48

    · Share on FacebookShare on Twitter
  • unklezwifeonty
    unklezwifeonty Member Posts: 1,710
    edited November 2009

    Dear Diane,

    Good luck for unveiling. Are you having any Avastin specific symptoms? My unveiling is 2 months away but I am getting itchy to know already :-)

    I hope the neuropathy subsides quickly.

    · Share on FacebookShare on Twitter
  • brena
    brena Member Posts: 458
    edited November 2009

    Diane48,

    Good luck with the unblinding, hoping you received what you wanted. There is light at the end of the tunnel, gets brighter the further you get from the treatment. Give yourself time.

    take care,

    · Share on FacebookShare on Twitter

Categories