Sutent Clinical Trial...

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taj72
taj72 Member Posts: 50
edited June 2014 in Triple-Negative Breast Cancer

My mother has the possibility of participating in a clinical trial for Sutent.  It is an anti-angiogenic targeted drug that is designed to inhibit the blood vessels that provide oxygen and nutrients to cancer cells.  She is Stage 3B, locallly advanced breast cancer with 1/2 suspected lymph node involvement, approximately 6 cm, Triple Negative.

If she participates, instead of standard DD AC x12, followed by weekly T x15, she would take the following: 12 weeks of weekly Taxol and daily oral dosage of Sutent, followed by 15 weeks of weekly Adriomycin and daily oral dosage of Cytoxin.  A total of 27 weeks of neo-adjuvant chemo and Sutent, followed by mastectomy.  The clear differences are the addition of the experimental drug Sutent (which is already FDA approved for treatment of kidney cancer and is being tested to determine its effectiveness in BC); the reversal of standard order AC, then T to T, then AC; the change from every 2 weeks of AC to weekly A and daily C (the doctor says continuous C on a daily basis rather than weekly or every two weeks is less toxic and more effective); and instead of a weekly neulasta shot during AC, she would get a neupogen shot daily for 6 out of 7 days.

The oncologist overseeing the trial is Dr. Robert Livingston (University Medical Center through Arizona Cancer Center in Tucson). Trial is being offered at Arizona Cancer Center and University of Washington.  Dr. Livingston says with chemo alone, we have a 25-30% chance of pathologic complete response (i.e., no trace of cancer after chemo and therapy), but that the Sutent may increase our chance of a Pathologic Complete Response and if so we have an 80% odd of cure vs. approx. 54% with just straight chemo.

Please give me your thoughts on this.  Do you think it matters that the AC, T is reversed?  Do you think weekly and daily doses vs. every 2 weeks are ok?  Do you trust clinical trials?  Anyone familiar with Dr. Livingston of Tucson?  Need to decide ASAP.  Mom has her port-a-cath inserted tomorrow and if she does standard chemo she can start right away.  If she does trial, she'll start in 2 weeks (she needs to give her body time to heal and form new blodd vessels from the port a cath insertion and since the Sutent interferes with and inhibits the growth of blood vessels we need to wait for proper healing before beginning Sutent).  Thanks for all your help.

Dx: 4/09; 6 cm; Stage IIIB/Grade 3, K167 90%, ER-/PR-/HER2- (Triple Negative)

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  • sftfemme65
    sftfemme65 Member Posts: 790
    edited May 2009

    I personally did a clinical trial.  It was E5103, with Avastin.  I dont know really know anything about Sutent but I personally think that the it looks like she will be getting good care.  I did the trial because I was going to get A/C and T regardless and felt that adding another drug could only help me if I was lucky.  I did Taxol weekly. 

    I cant tell you what your mom should do, but I can tell you that if it was me....I would absolutely do the trial.  She needs to do whatever she's comfortable with though.

    Teresa

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  • sftfemme65
    sftfemme65 Member Posts: 790
    edited May 2009

    I just noticed that Avastin and Sutent are very similar in how they work.  If you get a chance could you ask the doctor if there is a difference in them.  I would really appreciate it.

     Teresa

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  • FloridaLady
    FloridaLady Member Posts: 2,155
    edited May 2009

    Order you receive chemo does not make a difference and with early disease they just don't know the value of these drugs yet.  I received Avastin four years ago...why they don't know more about this drug I don't know.  I've done clinical trials also...do I trust them? Depends on the trial and drug and who is doing it.  I using a tx that is approved right now by FDA but not mainstream. This oncologist works two days a week for the FDA his comments about "most'" clinical trials...only 8% chance of helping you???

    The key questions is, will this trial cause more harm to you than help you?  I've only meet a very few patients that had problems with these drugs.  The problems only occured after long term use.  I know a lady that has had Avastin for two years.  Now she is having kidney issues.  So I think your trial may have benefits....but will do no harm.  This what's make a good trial and also a sign of a later phase of the trial for drug that has been around for awhile.

    Flalady

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  • taj72
    taj72 Member Posts: 50
    edited May 2009

    Thanks for your all of your comments.  Teresa, I will ask the doctor what the difference is between Avastin and Sutent when we see him next and post it for you.  Flalady, thanks for your insight.  My mom just had her port a cath inserted today and also a sentinel node biopsy which she had to do to participate in the trial.  There does appear to be some lymph node involvement, but we have to wait for the full pathology report to know for sure.  The doctor wanted to know before starting the trial so that they can determine if her nodes are cancer free at the conclusion of treatment to determine if she has a pathologic complete response.

    The trial doesn't seem likely to hurt anything, so we figure might as well go for it.  I'll let you know how it works.  Thanks.

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  • brst26
    brst26 Member Posts: 155
    edited May 2009

    I am a strong supporter of clinical trials!  I took part in the B-40 Clinical trial with Avastin (which also keeps blood vessels from forming or growing around a tumor--in essence starving the tumor and causing it to shrink).  I received TAC in that order and did just fine with it.  It seems to be a common regimen to reverse the order for certain cancers. 

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  • FloridaLady
    FloridaLady Member Posts: 2,155
    edited May 2009

    Remember Avastin was given too patients and I'm one of them five years ago outside of trials.  Avastin is a low risk drug with a long history before many rec'd it. The dose had been set by us within six month to first year.  There was very low risk factor or anyone behind us. You can't compare this too other trials. Sutent is another drug original designed for another cancer. (I'm still looking for "our" bc drugs?)  KNOW your drugs before starting the trial and also check in Germany because they do drugs about five years before us.  They had tested this drug four years before I rec'd Aroplatinum that did so much harm to many with zero benefit!  They had posted the finding FDA to see.

    You can't compare a existing drug with new drug to new inhibitors with no history.  This is where many triple negative ladies are...out of chemos into untried inhibitors or repeating drugs we have already done because there is nothing out there for us.

    Flalady

    Flalady

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  • brst26
    brst26 Member Posts: 155
    edited May 2009
    Avastin was only approved in treating lung and colorectal cancer in the past...not breast cancer.  Thus the clinical trials.  It was just approved by the FDA for treating metestatic breast cancer back in February 2008.  I don't agree with you, Flalady, that there is no risk (there is risk for taking Tylenol, not to mention more powerful drugs such as chemotherapy)...two women have died in my trial from gastrointestinal perforations from Avastin (though extremely rare).  However, I do agree that the benefits outweigh the risks.  You have to do your homework and find out what phase (I, II, or III) the trial is in.  Phase I trials are basically nothing more than experiments.  With a Phase III trial (such as the one I was on), they are testing an FDA approved drug for either another disease or a different time frame (I received Avastin in addition to chemo...and then for an additional 30 wks or 10 doses following surgery). 
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  • FloridaLady
    FloridaLady Member Posts: 2,155
    edited May 2009

    brst26,

    You need to do your research!  Many including me did Avastin outside of trials five years ago. I have proof if you like!  I'v also done three phase I/II trials and involved another right now. So please reframe from telling me how trials are ran and when you can receive off label drugs. I'm sure I'm about six  or seven drugs head of you. And Avastin is a gentle drug anyone can have side effects..read the data on, it and then go read Adriamycin,cisplatin or Taxotere they are high risk drugs. I said low risk not NO risk.

    You need to watch who you address and their history. I've been to three top clinic in the country under the care of five different oncologist, nine different chemos and over fifity chemo treatments, three surgeries and numerous off label treatments.  I know my disease and treatment options back wards and forward because there are so few researched treatments for triple negative. I'm now to the point my doctor relie on me to bring to the table my next treatment options.

    Phase III is a trial that people like me have paid the price for the next group.  I have the scar's and side effects to prove my dues have been paid!

    Flalady

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  • brst26
    brst26 Member Posts: 155
    edited May 2009

    No need to yell at me here...I have done my research--from the trial I WAS ON.  Please don't treat me like I'm stupid because you have done more trials...doesn't mean you are God on the subject.  Don't worry...I'll never post again on this site...you've made sure of that!  I was under the impression this site was designed to support women with breast cancer...apparently I was wrong....

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  • FloridaLady
    FloridaLady Member Posts: 2,155
    edited May 2009

    Did not call you stupid or treat you as such.  I just talk to you as you talk to me... as if I had no knowledge of the subject. Again when you speak down someone you better know who you are talking too and what they have been through. Many women on this site have been through so much and are very knowledgeable not from the research but from living it for years. From going from one treatment to another looking for hope and not getting any. Only the most toxic of trials and the ones with the least amount of hope are giving to stage iv ladies.  We are having to pave the way for others. 

    Flalady

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  • brst26
    brst26 Member Posts: 155
    edited May 2009

    How did I talk down to you at all?  The only comment I made to you was about "not agreeing that there was no risk".  The entire rest of my post was talking about women needing to research what phase a trial is in before beginning to gain the needed information that they need.  I still don't understand why you would think that was talking down to you...

    Why do you think I was on this site in the first place...in order to gain the knowledge that so many women have from their experiences with this disease.  But I'm a survivor too...and I know everything there is to know about my disease and treatment that I've been through.

    Whatever...

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  • sftfemme65
    sftfemme65 Member Posts: 790
    edited May 2009

    Ok wow this isn't really necessary Ladies, I think you both are right in several things you say.  I have a long history with Avastin.  I did a trial too E5103 which I think is much like yours Abbey.  My mother also used this drug, she had stage IV colorectal cancer.  She had weeks left when she started on treatment and lived 3 years.  I know without a doubt that with out Avastin she would not of lived as long.  Abbey is right, Avastin can be dangerous like many many drugs, it causes high blood pressure, bowl perfor. and others.  The blood pressure risk is  kinda high.  I didn't have it but my mom did. 

    I understand what you are saying Floridalady, it didn't make me sick like the a/c or taxol but Avastin did do so much damage to my sinus's that I had to have sinus surgery and it will never get completely better.  I dont regret taking it though. 

    Teresa

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  • sftfemme65
    sftfemme65 Member Posts: 790
    edited May 2009

    I hope you will stick around Abbey, there are many very nice woman on this site that will be able to give you wonderful information.  Im sorry this has gotten so nasty that someone feels like they have to leave.  Its awful.

    Teresa

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  • taj72
    taj72 Member Posts: 50
    edited May 2009

    I am new to all of this and I really appreciate everyone's input.  Even when there's disagreement, there's a kernel of information that I can glean from each and every comment, so I appreciate all of you taking the time to share your experiences and thoughts and comments with me.  My mom is going to do the trial.  She will start next Thursday.  I'll keep everyone posted on how successful it is and I will ask the doctor about the difference between Avastin and Sutent, Teresa.  Thanks for everybody's willingness to share their thoughts!

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  • sftfemme65
    sftfemme65 Member Posts: 790
    edited May 2009

    Your welcome!  I bet she does great!

    Teresa

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  • taj72
    taj72 Member Posts: 50
    edited May 2009

    Teresa, I had the opportunity to ask the difference between Avastin and Sutent and this is what I was told.  They are both very similar drugs, designed to do the same thing (i.e., inhibit the growth of the blood vessels that take nutrients and oxygen to the cancer cells).  However, Avastin is administered by IV and Sutent is administered orally.  Also, I was told that Avastin can have more serious side effects than Sutent.  At least from what they know so far.  Hope that helps.

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  • sftfemme65
    sftfemme65 Member Posts: 790
    edited May 2009

    Thank you so much for the info.

    Teresa

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  • taj72
    taj72 Member Posts: 50
    edited May 2009

    Hi Ladies!  My mom did her first round of chemo yesterday.  It went GREAT!!!!  She was given the pre-meds: steroid (Decadron), anti-histamine (Benadryl), anti-anxiety (Lorazapam) and something else I think, plus of course the Taxol.  The Benadryl made her very sleepy.  She slept through most of the infusion once the Benadryl was administered.  Then she slept most of the way home and most of the evening.  We woke her up to take her oral dosage of Sutent at 9 pm (which I had her take with a bottle of Ensure) and to feed her a light meal.  Then she stayed up until about 11 pm when we gave her a sleeping pill to go back to sleep through the night so that she was on a regular schedule and not messed up from sleeping all day.  

    She woke up Friday morning feeling great!  She wasn't sick, tired or anything, no apparent side effects at all.  She said she felt better than she's felt since before she had cancer!  She even looked better, perkier and like her old self.  I don't know if this is normal or if it's mental or if it's prayer, but I'm just thanking God that she had such a great introduction to chemo.  She was so resistant to it initially and really hated the thought of being in pain.  I know it's not all going to be this easy, but if she can just make it through the Taxol with this response, it will be such a blessing!  

    Has anyone else heard of this kind of response to Taxol? 

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  • sftfemme65
    sftfemme65 Member Posts: 790
    edited May 2009

    Its probably a little bit due to the steroids.  I had so much energy and pep the next day from them.  My onc said its normal.  Im so glad she did so well....oh yes the benedryl with ativan(lorazapam) nap, its the best in the world lol. 

    Keep us up to date.  She's lucky to have a great daughter like you!

    Teresa

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  • HollyHopes
    HollyHopes Member Posts: 497
    edited May 2009

    Ladies - can't we all 'just get along'???  We are dealing with plenty of stress already....no need for attacks or negativity with one another....

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  • tibet
    tibet Member Posts: 545
    edited May 2009

    Abbey,

    Pls come to this site and do not drop out.

    Ladies,It's ok to disagree but please ladies do not take it too personally. Posting on internet platform is not as good as face to face communication. Lot of things can be lost, so please do not take things negatively and no one is more expert than herself about the treatment she had gone thru and this site is not a knowledge contest either. We are all here to share, learn from each other.

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  • brst26
    brst26 Member Posts: 155
    edited May 2009

    So glad to hear that your mom did well with her first treatment, taj72!  That's great news. 

    No worries...I didn't drop out...I was just hurt that day (I would never imply that I knew more than anybody else).  I'm over it. I don't hold a grudge :)

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  • taj72
    taj72 Member Posts: 50
    edited June 2009

    I'm so glad you didn't drop out, Abbey!  I really appreciate how supportive and helpful all of you guys have been toward me and my mom.  It really helps me in getting through this and being a good support for her when I come on the boards and read everyone's comments and know that there are so many really great, strong women struggling through the same journey and SURVIVING with their compassion and humor intact.

    Although my mom doesn't really use this website, she did meet a woman in her chemo class that she really enjoyed talking and connecting with and they are going to be in the same trial and doing chemo infusions on the same day and approximate time so I'm hoping that she can find that same type of camaraderie in that relationship that these boards offer.  I think it really helps if you feel connected to someone that you know is going through the same thing you are.  I joke with my mom that chemotherapy sessions are like summer camp, you go off for awhile somewhere you might not have originally wanted to go, but oftentimes you come back with great  friends! ;-)

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  • taj72
    taj72 Member Posts: 50
    edited June 2009

    Hi Ladies!  Question...  My mom has started to notice a tingling sensation in her feet.  I am aware that this is a common side effect of the Taxol, but my question is are any of you familiar with any remedies or tips on how to lessen/eliminate this symptom?  Also she has noticed her urine is a dark yellow color, is this change in color a common side effect of the Taxol, do you know?  As usual, thanks for all of your help in advance!

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  • taj72
    taj72 Member Posts: 50
    edited June 2009

    Hi ladies!  Just an update.  My mom was supposed to have her fourth chemo round of Taxol today but her white blood cell (WBC) count was too low.  So she now has to delay the chemo and Sutent and have neupogen shots four times a week to try to raise her WBC count!  She hates needles and shots so this was REALLY hard on her.  She also has to wear a mask and gloves and avoid public places and crowds.  She's really not handling it well.  We're hoping that the WBC count goes up by next Thursday so she can restart chemo.  In the meantime, she is trying to avoid germs/people/etc. If she gets a fever of 100.5 or higher she has to go to the ER.  Has anyone else experienced this?  What is likely to happen if her WBC doesn't get better, do you know?  If she does get a fever of 100.5 and has to be admitted to ER, do you know what the protocol for treatment is?  Thanks for all your help!

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  • FloridaLady
    FloridaLady Member Posts: 2,155
    edited June 2009

    taj72

    They will give her antibiotics and this will usually bring the fever down.  They just hate to give us these in treatment because it deactivates the chemo dose.

    Flalady

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  • sftfemme65
    sftfemme65 Member Posts: 790
    edited June 2009

    Antibotics deactivate chemo?  I would love to read some info on this.

    Teresa

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  • taj72
    taj72 Member Posts: 50
    edited June 2009

    Mom's fever spiked again tonight, so she had to go to the ER.  She's waiting to see the doctor right now and has been waiting for the past 45 minutes but in the meantime, it appears that her temperature has gone down to 100 (it had been at 101.8 or so).  I don't like her waiting in the hospital given all the germs that are there.  She's got her mask and gloves on (which she hates because then she feels like she stands out as the cancer person).  Her hair started falling out a few days ago, so she had it all shaved off on Thursday morning.  It's just been a really rough week for her.  She starts the Neupogen shots on Sunday, how soon should they take effect?  

    Thanks for you guys all listening to this stuff and offering your comments, thoughts and well-wishes.  I've bounced around and posted in a few of the other topic areas but I always come back here for the most support.  It's a smaller post room and I feel more comfortable and not as lost here.  So thanks, Teresa, Abbey, FlaLady, NewAlex and Holly.  I hope that you are all doing well on your journey through this as well and hopefully one day I can be of some support to you. 

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  • brst26
    brst26 Member Posts: 155
    edited June 2009

    Awe...that stinks.  I hope she is feeling better and received good care in the ER.  I too had a problem with WBC count after my 1st chemo treatment...they gave me a shot of neulasta and sent me home.  That did the trick, my counts were all fine following that.  The nurses taught me how to give myself a shot of neupogen for 5 days following my day 1 treatment at home...and then the day after my day 8 treatment, I went in for a shot of neulasta.  I never had any trouble from there on out. 

    Let us know how she's doing!

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  • FloridaLady
    FloridaLady Member Posts: 2,155
    edited June 2009

    taj52

    Just checking on how your mom is doing...

    Flalady

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