Neratinib Clinical Trials

Hi again.  After having diarrhea on and off for  holiday weekend, I visited my doc on Monday. For the first time, my CBC was entirely within normal range, my bp, vitals, all normal.  So, why do I feel so bad?  because the newest concern is about liver damage, they ran a liver panel to compare with one done last Wednesday and the numbers there were off, and I was dehydrated. So, I was back in the chair for 1000ml of iv fluids to try to stop the cycle, and clear things up. Now I remember why i got a port!  too bad i had it removed...they stuck me four times before getting a good vein. I've stopped taking the drug until I see the doc again on Thursday. I was so disappointed!  but it doesn't mean I am out of it yet...they might just reduce the dosage and try again. Anyone else started on 240mg and then reduced?  how did that go?

Hi Warrior,

I dont think they will let you participate if you have been on another trial- or at least that is what my onc said. Someone earlier said there was a way to quit the trial you are on, have a waiting period and then get into the neratinib trial- I dont know anything about that though because I had not done any previous trials. I finished Herceptin April 2009- I think the trial requires that you finished the year of Herceptin within 24 months of starting the neratinib trial.

You see the doctor at 1 month, 3 months and then every 3 months for the firts year with an EKG and MUGA scan every 3 months- Im not sure about years 2-5 on the followup schedule. I have seen my doc, nurses and lab a lot more frequently due to the potassium issues from my extreme side effects- but most people dont react quite as strongly as I have to the drug.

Kristy 

This trial is not at my cancer center either, but IS at 5 different hospitals in Philadelphia - about an hour or so away. When I spoke to the trial coordinator, she said that after the initial visits, I would be seen by them quarterly for the year I took the drug. I would continue to see my regular onc for normal monitoring and after the initial year, they would track me remotely by getting reports from my regular onc. That sounded very workable to me.

THEN yesterday when I was at my final (!!!) check up with my rad onc, I mentioned the trial to him. He said that our cancer center will not take on a trial that they are going to lose money on, and since this one was sponsored by a drug co and not NCI, it prob didn't pay enough to avoid a loss so they would not do it. He said the large hosps in Philly have medical schools they make money on so they don't worry about whether trials break even or not and will take them regardless. Interesting.............

So I am going to go to PHilly for the trial, to start in the spring or summer, if everything works out right.

Frankie,

There are some other trials for Stage 3-4 women and they are seeing really positive things with neratinib- the new trial that many of us are on or tlaking about opened in Sept/Oct time frame and it is for Stage 1-1, after a year of Herceptin women. I dont know anything about whether there are people receiving the drug outside one of the trials or not.

Kristy

Snowgirlcathy- sounds like you are on the real deal if you are dealing with consistent diarrhea- the placebo doesnt seem to have any side effects according to my research nurse.

My potassium was back up to 4.7 yesterday so I am going back on the drug, taking 5 tablets (240 mg) instead of the full 240 mg dose. After two rounds of Grade 3 toxicity with low potassium, the guidelines said to hold med for 2 days, supplement potassium and get me back in balance and then dose reduce. I have to get checked again tomorrow to make sure I am staying in the right range and not going too high or too low.

Hopefully I will tolerate this lower dose a lot better- I have to admit I enjoyed the 2 off days without the side effects!!!

Kristy

KristyAnn - i asked earlier whether anyone had gone on the reduced dose...let me know how it goes for you. I was taken off on Monday and see the onc this morning. My liver panel was a little off from where it was last wednesday and they didn't want to risk liver damage, and the diarrhea left me dehydrated (and miserable) After three days off, i'm just beginning to feel better, so we'll see if a dose reduction is the answer for me.  Good luck!  Gail

Kristy Ann - I hope the lower dosage works for you! Like I said, that dairy REALLY got me but now I am able to tolerate in moderation. I had a few slices of pizza and a small amount of choc milk last night and so far so good. I cant wait for you to get to that point.

Frankie - I am stage 4. My 1st 6 week scan showed the mets had shrunk in half but since then, they have stayed the same. My Onc. & I are happy with no progression, would love to see it gone but this will do for now. I just know if I were able to take this and an AI for the estrogen, it would get rid of those spots!       

Good luck to all of you!!

GK - I started back at 200 mg after 2 days off, still waiting on the potassium results from this morning but I will say I am not having the cramping and diarrhea like I was with the 240 mg - so Im cautiously optimistic. My side effects werent completely cleared up with only 2 days off but the restart at 200 appears to be showing less in the side effects. I am hoping we find the balance between the potassium supplements and the neratinib dosage so I am not low in potassium or pushed to be too high!

Looking forward to the weekend- date night with hubby so I hope I have some appetite and not spend the whole time running to the potty.

Vicki- glad to hear of no progression- praying it will kick in and kill off even more cells for you!

Kristy

Sorry Lisa, you joined the club.  That's the way I felt from day 7 to day 11 when I finally went to the doc for iv fluids, and he took me off the meds to recover. So, take immodium NOW!  if you get on top of the diarrhea, it won't take over. I wish I had done that with the first wave, but I'll know the next time when I go back on (at a lower dose) next week.  Good luck!

Ladies, I have a question and I don't want to bother my docs office on a Saturday for something so trivial. 

Since I just started taking the trial drug and do not yet have my own "system down" regarding the drug vs. the immodium, timing of taking the drug, etc.  I would really like to skip the drug today and take my next dose tomorrow afternoon.  I am riding in an amatuer horse competition tomorrow and while it is just for fun, I certainly won't be in a position to handle "no warning, explosive diarrhea".

So my question is:  Is is acceptable to skip a dose so it does not interfere with your life?

Lisa

Weety, I am going to take the Sunday dose after the meet.  But if I take the Saturday dose, I will have diarrhea Sunday - during the meet - probably.  I am thinking the drug is like herceptin, as long as you get it all, missing one day is not going to hurt anything,  My herceptins trips were stalled several time due to holidays or the doc being on vacation

Lisa

Lisa - i don't have an answer to that problem, but a day probably won't matter in the long run. However, I wouldn't guarantee that skipping a day will prevent the diarrhea from returning since it took about two days OFF before I even approached a more comfortable state.  Good luck!  (I hesitate to say, let us know how it comes out...everyone around me has said that so many times as a joke, and I still think it funny, but not everyone does...you gotta laugh!) 

beebusted1 - it was on day three that i started to get an "off" feeling, like the "good" days were just before my next chemo infusion at the early rounds, then i had "loose" bowels (which being a constipated person most of the time) i welcomed.  However, it all turned explosive on the evening of day 7.  That's when i truly knew I wasn't on a placebo. Get your immodium in place, just in case. 

I started the drug on Wednesday- had loose BMs by Thursday and Friday and woke up Saturday hunting the Immodium. At one point I was taking 2 immodium in the morning, 2 at lunch, 2 in afternoon and 2 at night. Now that I am on a dose reduction (200 mg instead of 240 mg), it is not quite as bad but I am still dealing with the no warning, diarrhea- so Im still taking immodium.

I seem to have the worst problems about 6-9 hours after I take the drug so I usually take immodium about 5 hours after I take the drug.

Kristy- Im off until Wednesday for the next potassium check- sure hope I am holding my own this time around

HELLO LADIES,

OKAY GOOD NEWS AND BAD NEWS!

GOOD NEWS...MY WHITE BLOOD CELL COUNT IS NOW NORMAL AND I AM CLEARED TO START THE TRIAL!

BAD NEWS....MY DOC OFC FILLED ALL THEIR SLOTS AND I HAVE TO WAIT TIL JAN OR FEB WHEN THEY ADD MORE PEOPLE TO THE TRIAL. I WILL THEN HAVE TO DO THE BLOOD WORK ALL OVER AGAIN (SIGH). THEY DID HOWEVER SWITCH ME TO ARIMIDEX INSTEAD OF TAMOXIFEN AFTER SEEING MY HORMONE PANEL RESULTS. OH WELL I GUESS IF THIS WAS THE WORST PART OF MY DAY THEN I AM DOING PRETTY GOOD!

CHAT WITH YALL SOON AND I HOPE IT GETS BETTER FOR YOU ALL THAT ARE HAVING THE SIDE EFFECTS!

I WILL KEEP YOU ALL POSTED!

Well,  now it's Sunday and things seem to be settling down a bit. Last Thurs/Fri was the worst - non-stop diarrhea, cramping and gas so I couldn't stray far from the washroom at work - not good.  I went to see the Trial nurse, they did bloodwork to test my electrolytes and liver function, all was well.  Found out I wasn't using the Imodium properly.  If you go 12 hours without diarrhea then have an episode, take 2 pills.  Then each time you have a bout, take another pill right away - even if it's only 5 minutes apart - until it stops.  I was trying to take them every 4- 6 hours.  Once I took the Imodium the right way, Saturday was 'runs-free'.  Good thing since we took my granddaughter to the Christmas parade in town and washrooms were few and far between.  Between her potty training and me, we'd have been quite a pair.  Anyway, no episodes all day Sat, stools firmed up today but then I just had another bout of the runs so I popped 2 immodium.  I find the worst part is the nausea I experience for abt 3 hours after I take the Neratinib - too reminiscent of chemo for me!  I take half a gravol but then that makes me sleepy.  Sheesh, if it's not one thing it's another!  Maybe I'm not eating enough before I take them but that's the part I find hardest to handle.  Anyway, we'll see how the next few days play out.  I'll email the nurse tomorrow morning and see if she's contemplating reducing the doseage.  Hopefully this will all adjust itself in the next week or so!