Update on Clinical Trial - 1274025

Hi Dr. Creelan. It is a Pfizer drug, currently known as PF-06647020, being tested through clinical trial NCT02222922. The presentation on initial dosing and effectiveness from the early Phase 1 can be found here:
http://player.meta-fusion.com/late-breaking-abstract-a-phase-1-study-of…

The initial results on unscreened patients wasn't particularly strong for effectiveness on lung cancer, but my wife is in the second part of Phase 1, in the group of adenocarcinoma lung cancer patients that were pre-screened for moderate to heavy presence of PTK7. The drug is an ADC, auristatin payload, connected to an antibody against PTK7. We are doing it through University of Chicago (one of four US locations, the others being at Stanford, Scottsdale, and San Antonio). Her tumor is a HER2 mutation, but I have no idea whether the HER2 (almost all adenocarcinomas if I understand it right) also correlates with higher PTK7 expression.

My wife just had her third treatment, and her cough is now almost completely gone, so we continue to hope for future good news! The main side effect (which nurses say is common with the drug) seems to be what they think is some sort of nerve effect that causes pain in joints that randomly come and go. For my wife it shows up about the 5th day after treatment and lasts for about 5-6 days. Generally controllable with Ibuprofin, it causes a number of sleepless nights, as it appears to be much worse when resting or lying still.

Thanks for your interest!

Hi anypap.

Please - no need for any apologies. I remember all too well the first few weeks when they told us of my wife's diagnosis. Within 2 weeks we went from a diagnosis of possible unresolved pneumonia to stage IV lung cancer. I know this site helped me (and still helps me) to realize that I am not alone, and that there are many traveling this unknown road together. The people at this site have helped me enormously.

I am so sorry to hear of your father's diagnosis, and I hope he does well on his chemotherapy. As for the trial, my wife's oncologist knows many people at U of Chicago (we are in Chicago) and keeps track of the types of trials that are going on. He suggested we talk to the doctor running the trial, which we did. After some testing to see if she had the marker on her tumor cells for which this drug is directed (which she did) we were approved for the trial.

As for trials in general, you can look them up at: http://www.cancer.gov/about-cancer/treatment/clinical-trials/search

However, it is pretty overwhelming to try and sort through the large number of trials out there. Moreover, trials are generally only considered after you don't respond to (or have stopped responding to) first-line (and even second-line) treatments. Your father should make sure to talk to his oncologist about the nature of his cancer so that he (and you) feels comfortable about all the treatment options available, both now and potential ones in the future. You haven't mentioned anything about the nature of the diagnosis, so I don't know if they have done any molecular analysis of the tumor, but our trial doctor at U of Chicago told us that more and more the treatment methods are being determined by the molecular aspects of the tumor (e.g. if there is a known particular mutation causing the tumor) along with the extent and location of the tumor/cancer.

I wish you and your father all the best in the treatments, and may you all celebrate many future occasions in joy.

Hi Janine.

Thanks for the suggestions. We talked with the doctors and are hoping to stay away from the drugs like gabapentin for the time being if we can.

It turns out they aren't really sure what is causing this, so for her 4th drug treatment they are having her take some steroids for the first week, to see if it is due in part to inflammation. So far my wife says it seems to have cut the pain in about half, but is definitely still there, and still seems to be at least mainly controlled by ibuprofen (she is also trying naproxin this time to see if that works as well). My wife says it usually goes away as quickly as it comes, although for the last treatment it lasted about 2-3 days longer and was a little worse, so we hope it is not cumulative (have no way of knowing yet).

And, just in time for the wedding, it looks like the side effect of hair loss is starting to kick in. She is looking into getting a wig just in case……

Just a couple of weeks away now!
Thanks for your support!

Thanks Janine!

We have already taken care of changing the treatment schedule. Since it's a clinical trial we had to get special permission from Pfizer to delay a treatment by a week, so my wife won't have another treatment until we get back from the wedding. This week should be the worst in terms of pain, so it should mainly be gone during the time at the wedding. We also have another ct scan next week so hopefully it will be as good as the first one and we'll have lots to celebrate at the wedding!

Sure thing - although I will have to see how to post a picture. I just tried to post one of my son's graduation and wasn't too successful.

Thanks Denise!
To test it out, here's a picture of me, my wife and my daughter at my wife's recent retirement.

Picture works great - thanks Denise! I will post one of the wedding once we get back.

In the meantime, great news on the CT front - the latest CT scan showed an additional 30% reduction in the main tumor and 10-40% reductions in some of the liver tumors. The trial doctors were really excited!

So we go to the wedding with great results and happiness al the way around!

Well, here it is.

Just a brief update on the clinical trial. The drug continues to show activity with main tumor (and liver metastases) still reducing in size. The size of the main tumor is now definitely smaller than it has ever been since the first CT scan, including slightly smaller than it was after the 6 carbo/alimta treatments. As importantly, the drug also seems to be working on the liver metastases.

There does seem to be some continuing nerve pain that comes on about a week after the treatment, and lasting about a week or so after that, but the gabapentin is keeping that in check. My wife is also doing some acupuncture, but she is not sure as to the extent that it is reducing the pain - for a couple of the treatments it seems to have worked well, but relief is short-lived. The gabapentin and massaging some acupressure points in the hand seem to work best.

My wife and I were joking yesterday that if this drug ever goes to market we think the patients on the drug should have a shot at coming up with a good trade name for it.

As always - thanks to everyone for their continued support and encouragement.

Well we had a few thoughts (based on the fact that almost all trade names in with a vowel for some reason) -
We could go with the fact that many of the new ADCs have ADC in their name and go with:
ADCETERA

Or go with the hope for great things and try
BOYOBOYA
WOWZIRA
AMAZMIO
TUMORSKIDOO

Or my wife thought since it is in a clinical trial still, perhaps just go with
POSSIBLA

Frustrating week.

My wife went in for her weekly check-up that included the report on the CT Scan, and was told that everything was still shrinking. When she got home, she handed me the report - which I noticed had been that of last month's CT scan. After about a week, we finally got the report of this month's CT scan, which showed that although the liver lesions had still decreased slightly, there appeared to be a slight increase in the main lung lesion. Our understanding was that they were going to change to a maintenance dose once the tumor got to that point, but didn't, giving her a full dose of the drug, apparently due to reading the wrong CT scan. The report did say there was some increased atelectasis which made the tumor size hard to measure, but the frustrating part was that nobody was getting back to us for several days about the apparent discrepancy.

She has an appointment with the clinical trial nurse this Wednesday so we'll see what happens.

Thanks Janine. I'm sure we'll get through it, but these days any increase, especially when the Dr. wasn't there to explain it, brings back those anxieties. Hopefully the Dr. will get back to my wife this week and let her know what's what.

Hi lynnandpete!
I am so sorry for your husband's diagnosis, and that the first few treatments didn't work. I'm also sorry I missed your earlier post - I would have responded sooner. I hope it helps (I know it does for me) that you're not alone, and that there are other POSSIBLA (what my wife and I made up and call the drug) patients out there. The support and encouragement of others has been a big help for me. Is your husband also on PTK7 targeted PF-06647020 or is it a different Pfizer drug?

Don't know if the side-effects will be the same (they tend to vary somewhat for each person I suspect) but here's a few thoughts.
My wife's main nerve pain generally lasts about 5-10 days and starts about 4-5 days after treatment (although oddly on a couple of treatments they started about a week later than that). The pain definitely got a little worse each time, but she started taking gabapentin about the 4th or 5th treatment, which has definitely made the pain very manageable (she is currently on 600 mg - 300mg 2x a day). She's also on acupuncture, although she never tried the beer!

My wife also had a terrible cough, and the only thing that has seemed to control it when it came back was some over the counter dextromethorphan tablets. Sucking on riccola or other strong cough drops only helped temporarily.

The only other side-effect I should mention is a rash. Somewhere around the 6th or 7th treatment she started to get a very itchy rash (same timeframe as the pain - about 5-6 days afterwards) for which she now takes some low dose steroids.

Best of luck in managing the side effects, but more importantly I hope that POSSIBLA works well for your husband, and for a long time.

Sending love, prayer, and hugs to you both,
scohn

Hi Janine.

Yes, my wife's clinical trial oncologist (and her regular oncologist) always meet to go over the CT scan results prior to them being released. We really like that approach. It was just that in this case the doctor went over the previous scan results instead of the current one.

All is good now. Thanks for all the support during an anxious week. The nurse navigator apologized for the situation (even though she had been out of town and didn't have anything to do with it) and said she would always be available for any and all questions we have. The clinical trial nurse said that they are not at all concerned with the apparent minor increase in the lung at this point, especially with the liver lesions still decreasing and no new lesions appearing, and that the treatment will be continued as normal. The clinical trial doctor is currently out of town and will talk to us in a couple of weeks when she gets back. The U of C team has actually been really great, but when it comes to cancer these minor "blips" can still get to you….

lynnandpete - my wife is usually at U of Chicago on Wednesdays as well, although I think she is going on Thursday next week because of Yom Kippur. Her appointments are usually in the morning, although on the days of the infusion it is most of the day.

She also was given some steroids for the nerve pain at first (hers is mainly in arm instead of leg) as they thought it might be inflammation from the drug. The steroids didn't really have any effect on the pain, but the gabapentin seems to do pretty well. If you similarly find the steroids are not doing anything for the pain, you might want to check with the doctor regarding whether gabapentin would be appropriate or not.

Hi lynnandpete!

I'll check, but my wife has not had much digestive problems with this drug. She had a lot with the Opdivo, and had some reflux heartburn and digestive problems when she was on the steroids when she took Carbo/Alimta, but on this drug the digestive issues have been mostly well under control. I would check with your oncologist to see what they think. I believe that, as there often is, the side effects of this drug vary quite a bit from patient to patient. At least with my wife the general trend seems to be the same, where the side effects start about 4-5 days after the main infusion of drug, last for about 10-14 days, and then ease up just in time for the next treatment. The gabapentin has worked great for her in reducing the nerve pain, and we're still working out the right timing/dosage for the steroids to help with the itchy rash.

Not sure if any of that info was of help to you - but we'll be thinking of you, and hope to meet up some time!

OK - latest update.
The CT scan shows the main lung tumor is starting to grow again at the normal rate, but the liver lesions are essentially stable (a little growth in one, a little shrinking in the other). So my wife had another POSSIBLA treatment for the moment.

However, the basic idea is that the clinical trial doctor thinks it is time for a change of treatment. Not sure what it will be yet, but it may be a trial drug that I had stumbled upon a couple of months ago and showed my wife a couple of weeks ago when we thought POSSIBLA was losing its oomph. It's a drug that they just started doing Phase I trials on in Denver (and elsewhere) and will be available in Chicago in a couple of months (with the same trial doctor we have here in charge of the Chicago site). It is a new drug developed specifically as a TKI for HER 2 Exon 20 mutations (and EGFR Exon 20 mutations). So we are talking tomorrow with my wife's regular doctor about the possibility. According to my wife (I wasn't there) the trial doctor at U of C thinks it may be a good next option.

Another possibility brought up by the doctor was a couple more rounds with POSSIBLA, and if it is still showing growth in the main tumor, stability or shrinking in the liver tumors, and no new metastases, then doing a PET scan and if it only shows up on the main tumor doing some local radiation. The trial doctor said even if the PET scan shows only activity of the lung tumor, surgery is probably not really an option given the area of partial lung collapse around the tumor being close to the main bronchial tube (or something like that). I suspect if that ever got to be even close to an option we would be conferring with the pulmonary surgeon.

So that's mainly it - probably nearing the end of the road with POSSIBLA alone and looking towards POSSIBLA and radiation, or AP32788 (we're going to need another name…). Perhaps our talk with the regular oncologist tomorrow will cheer me up from the election.

Lynn and Pete,
Sending healing hugs for a quick recovery of the bronchitis! I am glad the gabapentin seems to be helping - It made a lot of difference for my wife's nerve pain.

I am sorry to hear the POSSIBLA (glad to see our name is catching on) didn't seem to have much effect in the first two treatments. Hopefully it will help in the next one. We'll keep the two of you in our hearts and prayers for the ADC to start kicking in and working!

As for us, the regular oncologist also thinks the new trial would be a good thing to try and get into. (But then we would have to come up with a new drug name.) My wife scheduled the PET scan before we go to Denver to see family after Thanksgiving, in order to assess the degree to which POSSIBLA tamped down the cancer. At that point we would see if radiation was an option, but at the same time we are trying to organize the possibility of the new trial drug. It basically is thought to work the same as afatanib (which my wife already has approval for if needed) only better (less side effects as it works more specifically on the mutated cells and less on the normal ones). One issue we hadn't considered that the oncologist brought up is that if we irradiate the main tumor first we would need to check if we would still be eligible for the new trial study as it would make the tumor a poor candidate for trial study measurement since much of the tissue would be dead and the size and shape changes over time.

So, the next month or two will be filled with decisions for us as we determine all of our options.
We look forward to Thanksgiving with all our kids (and our new in-laws will be there as well) followed by a niece's Bat Mitzvah and then my Dad's gravestone unveiling - hard to believe it has already been a year.

But, except for my wife's cough which has definitely returned, she feels good (other than the election….)

Best wishes to all for a Thanksgiving full of family, and love, and friendship.

Just got the PET results back - here's the upshot.
Between the Carbo/Alimta and the POSSIBLA the cancer was pounded down, but not out.
The number of liver lesions appear to be down, but metabolically active cancer still in the liver, the lung tumor, and (disappointingly) the three bone lesions that had all shown bone repair and we thought were gone.
So, good news - no new metastases, and lesions are smaller than when we started - Bad News - all the old ones, while much smaller, are still active, and if the last CT is holding true the main tumor at least, and possibly one of the liver lesions, is starting up again. It seems as though each new treatment, when effective lasts for about 6 months, and then.....

So, my wife has an appointment for Monday with the next (last?) dose of POSSIBLA, but it looks like we are destined to see if we can qualify for the next trial drug, a HER2 inhibitor, for which the trial is currently ongoing in Denver, and will soon be coming to Chicago. If she can't get into the trial for some reason, she will likely be switched to afatanib. Take a deep breath and onward we go! Looks like the next month or so will be destined for another transition.

But no worries - she still feels great, we've got a lovely Thanksgiving weekend planned with all the kids and the new in-laws coming in. We are blessed with friends, family, and love - and for that, Thanksgiving still warms the heart.

Warmest wishes to everyone out there in CG-land, and may your Thanksgivings be filled with all the blessings of love your heart can hold.

JimC - thanks for the warm words of community. It's always nice to know that there are people out there in a connected community of caring. I hope you will be having a wonderful Thanksgiving as well.

Lynn - so sorry to hear of your pneumonia. Glad you are out of the hospital and on the mend. And I hope Pete will begin to feel better as well as he gets more of the POSSIBLA out of his system, and that your holidays will be that much brighter for both of you. Thank you so much for your kind thoughts as well. From the moment my wife got her diagnosis we have found so many people going on so many different journeys. It helps to know there are others out there rooting for you! And healing dances of sugar plum fairies sounds awfully nice for everyone.

All the best, scohn