removal from clinical trial because of recurrence?

Renairis
Renairis Member Posts: 38
edited June 2014 in Triple-Negative Breast Cancer
removal from clinical trial because of recurrence?
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  • Renairis
    Renairis Member Posts: 38
    edited October 2007

    My ocnolgist told me that I will be removed from  the clinical trial I am presently participating in if a PET scan indicates recurrence of mets.

    I have had 8 rounds of taxol and carboplatin along with Avastin (trial drug) and am now taking avastin alone- which is part of the  continuation of the trial.My last ct a few months back indicated remission.

    Because I haven't been feeling well I asked to have  a PET scan which was the test that originally showed recurrence and mets. My oncologist "warned" me that if the PET scan shows any type of recurrence I am automatically taken off the trial. He said that this is the policy for all trials : cessation of being a trial participant if there is any deterioration.

    The onclogist told me I should wait and have my regular ct(once every 3 months)  and even if there is a recurrence it will less likely show up on the ct scan as opossed to the PET scan. This will enable me to be part of the trial for a longer period. He said that in metastisized bc it's not crucial for early diagnosis and I don't need to have a test that will indicate recurrance by a more definitive way than the ct.( In essence he meant that a pet scan will decrease my chances of staying on the trial because it will show recurrence more quickly than a ct)

    I realize that if there is a recurrence, avastin alone may not prevent recurrence, but it may slow it down, or be benificial to other chemotherapy treatments.

    1. Does every trial remove its particiapants if they have recurrence while being part of the trial?Is this trial policy?

    2.Is ther no advantage to early detection of  recurrence mets?

    It would seem to me that the more accurate the test,and the sooner the discovery, the better!

    I'd appreciate any input on these matters especially because I wonder if I'm being mislead both medically and policy wise.

    Rena

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  • TenderIsOurMight
    TenderIsOurMight Member Posts: 4,493
    edited March 2008





    I don't know the answers to your question, but it sounds like you may wish to read the transcript of last weeks' Ask the Expert Conference on "Living with Metastatic Breast Cancer":



    link: http://www.breastcancer.org/community/ask_expert/index.jsp



    During the conference, I seem to recall Dr. Norton, of MSK (Memorial Sloan Kettering, NYC) suggested just the opposite regarding scans and chemotherapy.



    Hope this might help you,

    Tender

    Edit Addendum: Here, I scrolled through the Conference and found the question and answer:

    Adjust treatment to improve quality of life?

    Question: "Getting PET/CT and MRI scans every 3 or 4 months was having such a negative impact on my quality of life, I asked to go on a 6-month schedule instead as long as I'm feeling great. Am I making a big mistake?"

    Answer: Larry Norton, M.D.:

    "The answer is perhaps. This is a question that only the oncologist treating you can answer. However, I have some general rules. Doctors listen very carefully to the message the patient is sending about how they want to deal with their disease. A patient by their actions or words or attitudes can be saying, "Whatever you do, don't hurt me." In other words, don't do tests that make me anxious. That is often the wrong message. The right message is, "Doctor, whatever you do, make me well." If your doctor feels a patient's primary goal is to avoid tests or information, then important tests or information may be excluded and that could be a mistake. Make sure your doctor knows you're there to win."
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  • Shirlann
    Shirlann Member Posts: 3,302
    edited October 2007

    Well, I am surely not an expert but it looks like they want you off because you are messing up their test? I hope I am way off here, but how can they truly test something if people on whom this new thing doesn't work are booted off?



    I know absolutely nothing about you or your trial or any trial, but a few pointed questions come to mind.



    I would think they could at least give you a careful explanation of what their thinking is.



    Hugs, Shirlann

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  • CalGal
    CalGal Member Posts: 469
    edited October 2007

    Rena -

    I'm sorry to hear of your dilemma.   

    You didn't mention how long you've been on this trial (in this post) .. and when your next trial-ordered CT scan is scheduled (only that it is every 3 mos) ...

    I too am on a clinical trial, the PARP Inhibitor aka ICEBERG1, which is at a different hospital than my "main" one ... where I've been getting PET/CT scans quarterly.  I asked for a PET/CT instead of a plain CT scan, but was told no, that's not the trial protocol (and that if I really wanted one, I could ask my other onc).  

    I think we've both read that Carboplatin is a good option for us trip negs ... and Avastin is one of the "wonder" chemos ...

    So, there's a number of questions you need to ask yourself:

    1.  If you're having progression on this trial,

        A) Do you want to stay on the trial?

        B) Do you want to know sooner or later?  

    2.  Ask your onc why he wants you to stay on the trial?   Does he think it will work for you, but take longer?   (He may have an outside interest in keeping you on the trial - not that he/she would mention it, but if he can't give you a good reason ...) 

    3.  Personally, I think there is good reason to catch mets early - so that they can be treated before they interfere with organ function!  

    4.  How are you feeling poorly (and why do you think it might be mets)?  As one who has been dx with liver (gone now!) and lung mets, I never had any  symptoms ... and it seems that many with mets don't ...  

    5.  Have you re-reviewed all of the clinical trial info and papers you signed, to see if they provide any add'tl info? 

    As you're BRCA, you might be interested in the trial I'm on.  Is the PARP INHIBITOR clinical trial (by KUDOS, a subsidiary of Astra-Zeneca) available in Israel?  It's an int'l trial .. with the headquarters of the pharmaceutical company in England (and I know it's available there and in Australia) ... and shockingly, although only open to 40, it has not filled up when I last inquired.  

    I got my 8 wk results on Tuesday - and my 2 cm lung met shrunk 25% to 1.5 cm!!!   I'm so thrilled ... and want others who are eligible to know about it.  The trial is NOT chemo!  And, it's pills (16/day) instead of an IV!

    Best to you in making this decision. 

    CalGal 

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  • Traci-----TripNeg
    Traci-----TripNeg Member Posts: 2,298
    edited October 2007

    CalGal.....Congrats!!!! That's great news girl!

    Rena, all I can say is....I would want to know sooner rather than later. And, I wish you luck girl. Go with your gut. You seem to be asking all the right questions.....

    Hugs, Traci

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  • PineHouse
    PineHouse Member Posts: 416
    edited October 2007

    Hi Rena,

    I know it really sucks if they kick you out of the trial if you're found to have a recurrence.  But the thing is, it probably makes sense to stop taking whatever drug you're on if your disease progresses while taking that drug.  Maybe that's what it means when they say they're going to kick you out of the trial... because you're not going to be taking the drug (in this case Avastin) anymore.

    You indicated that you were on Avastin+Taxol+Carboplatin and now on Avastin alone.  Were you taken off the Taxol and Carbo because you got into remission?  I had the Avastin+Taxol regimen myself last year.  The combo worked great at first but then it stopped working, so I was switched to a different regimen. 

    I'm a big believer in Carboplatin.  If the Avastin is proven to stop working for you, you can always go back to Carboplatin, for which you don't have to be in the trial.  Also, you may want to investigate the PARP Inhibitor trial that CalGal mentioned.  I happen to be on the same exact trial, except that I'm still too new to have a scan right now.  There is also another trial for a similar drug, although I don't know the details of that. 

    Is it possible for you to consult with another oncologist?  All we want is what is best for you, whether it's within trial setting or outside setting.  If it was me, I would (eventually) get a PET scan that will tell me a more definite diagnoses of either a recurrence or a continued remission.

    Hope things work out for you.

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  • Renairis
    Renairis Member Posts: 38
    edited October 2007

    HI

    Your responses,questions and suggestions are helping me think this through.

    I read the contract I signed for the trial and so no indication that particpants would be taken off the trial as a result of progression of the cancer. There is a clause that indicates that the oncologist can decide to take a patient off the trial if it is not helping the patient (or harming).

    I was told by him I would be taken off because on trials any progression automatically requires removal from trials.

    I would like to know if this is trial policy or his personal opinion or decision

    I am sceduled for my regualr ct in a few weeks but my dilemna is I feel that the pet is a more reliable test.

    He told me if I take the PET I don't have to take the ct. I don't know what this means either about ct protocol and if my NOT taking a ct will then further make me uneligble to particpate in the trial.

    I want the pet because I'm feeling similar symptoms as to what I felt when it was first dicovered that I "graduated" from stage 1 to stage 4.(Pains in my arm and breast on the side where I had my lumpectomy and lymph nodes removed. I also have pains in my back and chest pressure. A recent bone scan was, thank G-d, clear!Twice the PE scans have given an accurate picture of my condition.

    I want to make sure that my common sense is not going to interfere with my getting the best possible diagnosis and treatment.

    I will consult with another oncologist from another hospital.

    Again I so appreciate your input!

    Rena

      

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  • jeanne46
    jeanne46 Member Posts: 1,941
    edited October 2007

    Hi Rena,

    I, too, am in a clinical trial and my documents state that disease progression, as measured by CT scans - after a specific amount of time, (not my usual PT/CT and whole body bone scans) will preclude me from continuing in the trial. Also, I can be excluded if my onc believes it is in my best interest to be on another chemo protocol. I believe each clinical trial sets its own measurements and tests that it uses to determine efficacy.



    Not sure exactly what your trial involves, but if you feel strongly about wanting to get a PT scan, I would encourage you to go ahead. Just last week (2 weeks before my next scheduled CT scans) I had a MRI of my spine due to terrible sciatica. If that had shown tumor, I would have been out of the trial then. However, I also would have been treated immediately for the bone met progression. Also, "If" the avastin alone isn't working and you do have some progression, then it seems like a good idea to switch to a chemo protocol that will work. If all is well, then you have peace of mind. Your onc sounds a bit consumed with the "trial" and not the patient. You need some clarity and understanding from him as to what will make you feel better.



    Best of luck.

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  • FloridaLady
    FloridaLady Member Posts: 2,155
    edited October 2007

    I did a Phase I trial this year and was told the same thing.  Progression after 2 months of trial will knock you out of trial. They would only use CT scan and not PET. PET would more likely find more disease.  I'm surprised your combo of drugs was a trial.  I had these chemos last year.

    I would push for PET now.  This is not the right combo for mets.  They would use Abraxace (Spell?) or Gemzar.  You need to remember if these fail you can not use them again.  I have been told this many times.  They may mix Avastin with two new chemos.  But usually you don't get the same twice.

    Living in Hope

    Flalady

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