Clinical Trial NCT01121575, continued - 1241613

gn21
Posts:144

Today I signed on for the PF 02341066 and PF 00299804 combination trial. Any one out there on this one, and if so, I'd love to hear about your experiences to date

Gail

Now to see whether my signature block has survived the upgrade........

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Reply # - February 13, 2012, 03:37 AM

cards7up
Posts: 635

I noticed one is for ALK and the other for EGFR, that's strange that you'd be on both. Do you know why this is? Wishing you the best. Take care, Judy

Reply # - February 13, 2012, 01:41 PM

certain spring
Posts: 762

Ah, gn21, it's you! I never knew your name was Gail. I have spent some time hunting for the thread on which we discussed this previously:
http://cancergrace.org/forums/index.php?topic=11019.msg89960#msg89960
Like Judy, I was puzzled at the time by the inclusion of crizotinib, but as I remember this is crizotinib in its capacity as a c-MET inhibitor, the point being that by combining the two drugs you have all your Tarceva-resistance bases covered. Dr Pennell explained it thus:
"This type of strategy, i.e. combining a MET inhibitor with an irreversible EGFR inhibitor (technically pan-HER as was pointed out) attacks resistance in 2 different ways. One is the combination of inhibiting both MET and EGFR, and this would likely be most effective in patients whose progression is caused by activation of the MET pathway rather than T790M or other mechanisms.
The irreversible inhibitor itself also has potential to overcome resistance, even possibly due to T790M, so the combination of both makes sense to cover all bases. Of course, to date all the data supporting this strategy is preclinical so the trials will really be the final proof. I do think this is an important strategy though, and a very reasonable option for a patient with acquired resistance to Tarceva."
At one point, Myriam (fortmyr's) sister was considering this trial, I think at MGH in Boston. For anyone who is interested, there are sites in Colorado, Boston, Maryland, and Melbourne, Australia:
http://www.clinicaltrials.gov/ct2/show/NCT01121575
Anyway, gn21, this is a long-winded way of saying good luck good luck good luck!

Reply # - February 13, 2012, 01:45 PM

fortmyr
Posts: 128

Yes, my sister was interested in getting on this trial but the problem was that to enter the trial, the patient had to have a tumor that could be biopsied, which was not the case with my sister. I'm glad to hear that it was feasible for you Gail,

Myriam

Reply # - February 13, 2012, 06:33 PM

cards7up
Posts: 635

cs, thanks for finding the previous discussion. I missed it and see it makes sense now. Good luck Gail in your trial. Take care, Judy

Reply # - February 13, 2012, 08:48 PM

Dr West
Posts: 4735

Not much to add, except that crizotinib was actually initially developed as a c-MET inhibitor before it was studied as an ALK inhibitor, almost as an afterthought, just a "why not try it?" experiment in a few people who were found to have an ALK rearrangement. Now its potential utility as a c-MET inhibitor has become thought of as secondary, but it's a potentially valuable strategy.

-Dr. West

Reply # - February 13, 2012, 10:37 PM

gn21
Posts: 144

Thanks all and in particular for the quotes from Dr Pennell. Myriam - we are also struggling with the biopsy side and are having to do it some unusual way that may require a different hospital as Peter Mac (our specialist cancer centre) may not be able to do it. Last PET last week showed up 2 new spots that doctor thinks are in the actual lining of the lung and provide a possible explanation for rib pain I have noticed (which of course I decided were bone mets!). Not actually sure which is better though! Currently getting all the pre stuff organized including brain scans, Eye tests, and the biopsy itself.

Are the doctors aware of any preliminary results from this trial?

Gail

Reply # - February 14, 2012, 05:21 AM

fortmyr
Posts: 128

Gail, would you mind telling me more about the way that your biopsy will be done? May be that could apply to my sister too?

Thanks for your help,

Myriam

Reply # - February 14, 2012, 04:54 PM

waddell
Posts: 2

Hi gn21. I started on the PF-234 and PF-299 clinical trial in Maryland during January 2012. I started on PF-234 (Xalkori) last month and PF-299 was added last week. Previously I had been on Tarceva (I'm EGFR positive) and had a good ten-month run but stopped when the Petscan showed progression. So far I haven't had any side effects from the medications and have been pleased with the trial. With regard to the biopsy, they removed some lymph nodes from my neck area. I hope this helps! I'm a 56-year old woman who is in good health other than the stage VI NSCLC adnocarcenoma.

Reply # - February 14, 2012, 07:20 PM

Jazz
Posts: 279

This trial is offered at the Univ of CO (where I go for the afatinib-cetuximab trial), and as I expressed interest in it, my oncologist said "Definitely no way, it's a Phase I trial!" So I'm glad this thread has been started. Gail and Waddell, I hope you'll keep us posted on your experiences.

Waddell, did your biopsy show c-MET amplification? Or are you T790 positive or negative? In other words, what were your biopsy results and did that determine your choice of this trial?

Best of luck for continued success (and for uneventful biopsy, Gail)!

Jazz

Reply # - February 15, 2012, 03:06 AM

waddell
Posts: 2

I haven't yet seen the results of the biopsy, but it wasn't a requirement of the trial that the biopsy results show those particular mutations. Rather, the fact that I was on Tarceva for six-months and had progression was adequate. They knew that I was EGFR positive because of a prior biopsy. I'll let you know when I get the biopsy results.

Reply # - February 15, 2012, 12:24 PM

Dr West
Posts: 4735

They tend to not have molecular marker requirements for phase I trials, where the question is primarily about the safety and tolerability of a new drug or combination at a given dose level.

-Dr. West

Reply # - February 15, 2012, 01:30 PM

certain spring
Posts: 762

waddell, thanks for posting about your experience with the trial, and very glad to hear that your health is generally good.

Reply # - July 9, 2012, 10:19 PM

Jazz
Posts: 279

Just for clarity, Gail's old thread, "Clinical Trial NCT01259089" is here:
http://cancergrace.org/lung/topic/clinical-trial-nct01259089/#post-12441

Thought I'd post that since this thread is still open and the one above (which contains a full discussion) is closed! Perhaps the conversation can be continued here.

Gail, good luck with the addition of crizotinib. I hope it gives your disease a one-two punch, and I hope you can weather any other side effects. Bali sounds delicious!

Jazz

Reply # - July 11, 2012, 01:38 AM

gn21
Posts: 144

Now I'm really confused. I thought this thread was closed and the other open and active. But now this is active and the other, which went for 5 pages can't be found, at least not by me! Clearly I am not coping with change. The thread that I now can't find is the most up to date and had lots of info in it. It doesn't appear in my profile but then again it never did.

Gail

Reply # - July 11, 2012, 07:47 PM

Dr West
Posts: 4735

Mark has been making some changes, so it's possible he moved things around or changed settings. I'm learning as I go. We've also found that the forum software isn't always behaving because it's relatively new... it's therefore possible that changes are being made to accommodate the vagaries of the software as we (the royal we, mostly Mark) learn how to adjust to curve balls.

-Dr. West

Reply # - July 13, 2012, 03:36 PM

catdander
Posts:

Jazz, is this the thread you suggested we change the name of to reflect a continuation of 1259089 thread?

If so I think i can do that. We need to make sure this tread will remain open, who knows why it might not but let's make sure. What do you want it to be named. It won't hurt to go ahead and change it.

Wow I might be handy...let's see.
Janine

Reply # - July 13, 2012, 03:45 PM

primarymark
Posts: 61

Yes, this thread will remain open, if you want it to. This was the original thread, created on the main blog (it was actually created in the wrong area originally), before the forums were split out to the individual cancer sub-type areas. I added a link to the older (2nd thread) pointing back here. The older thread is here:

http://cancergrace.org/lung/topic/clinical-trial-nct01259089/

Reply # - July 13, 2012, 04:50 PM

Jazz
Posts: 279

Well, it appears my last post telling Gail I posted a link for the "1259089" thread on this thread etc. didn't take! Second time this has happened, where the post completely disappeared.

To clarify, I believe Gail (and others) would prefer the "Clinical Trial NCT01259089" thread to remain open, as it has quite a bit of info, re: side effects. This thread doesn't have much content, so it can close. This will also save Janine from having to move it!! But thanks for the offer. Now if I can just get this to take...

(using Safari 5.0.6, OS 10.5.8 MacBook Pro)

Reply # - July 13, 2012, 04:53 PM

Jazz
Posts: 279

Although I just noticed that the ACTUAL title of that thread is "...NCT01121575", which was the wrong number, but we knew that was the PF299804 + crizotinib thread.

Jazz

Reply # - July 13, 2012, 05:14 PM

primarymark
Posts: 61

Jazz,

Actually, you picked the one option that isn't possible. The old forums will all remain closed, and will likely eventually go away, but for the time-being, they are being left as read-only for reference.

The NEW Discussion Forums will be the only active (open) forums from here on out.

There's really no benefit to closing this current thread, but if you want to start a new one with a different title, as a continuation of the older "NCT" thread, that's certain something you can do, and then I can help you link to/from the older thread. If you do so, then this forum will probably just die out where it is. I could close it and point it to the newer one (if you create it), but it seems like that would further split people's attention, and it would be better to just keep this one going.

If you want to discuss a specific trial, I'd recommend creating a separate topic for each one, which will help keep things on-topic. If you would like the name changed on this topic, with gn21's approval, I'd be happy to make the change for you.

Let me know,

-Mark

Reply # - July 13, 2012, 05:24 PM

Jazz
Posts: 279

I vote we let Gail (gn21) change the title, as it's her thread. And as she's now adding crizotinib to her treatment, I'm hoping this discussion keeps going. So please, keep this thread open if we can't re-open the other one (NCT0125...etc)

Thanks,

Jazz

Reply # - July 16, 2012, 12:20 PM

gn21
Posts: 144

Hi to all and thanks Jazz, Mark etc for ensuring this link remains open with the history. I hope it goes for a long long time and others who join the trial chime in with their experiences.

I have now been on the added crizotinib for 5 days with no unbearable side effects. Nausea in the morning was a problem but I think I have beaten that with the old pregnancy cure of toast. Appetite has gone again but I seem to find it does each time I change drugs.

Energy is good, as is life!

Gail

Reply # - July 19, 2012, 11:55 AM

gn21
Posts: 144

Thank you webmaster of the universe!

Update on treatment:

I commenced on crizotinib about 10 days ago. Have had 2 long days in Peter Mac as they do 2 hourly book tests for hours upon hours!

Side effects minimal, and combined with the reduced dose of PF299804 energy levels had returned to near normal. Won't know whether anything is working for another 4 weeks but at least I am feeling good, and able to enjoy my 5 nights in Bali in a fortnight.

Gail

Reply # - July 19, 2012, 12:02 PM

certain spring
Posts: 762

That's wonderful about the side-effects clearing up. "Feeling good" gets my vote.
So (I am confused) you are on crizotinib plus one of the two trial drugs?
Bring on Bali. I imagine it as full of birds of paradise?

Reply # - July 19, 2012, 08:21 PM

Dr West
Posts: 4735

Good luck, Gail. We'll be eager to hear news from you.

I hope you enjoy Bali. I remember it as being very, very hot, with extraordinarily gracious, friendly people. And lots of monkeys.

-Dr. West

Reply # - July 21, 2012, 04:11 AM

craig
Posts: 330

Don't assume that phase I trials are always just a gamble. Sometimes the drug has been used before and early results seen by the research oncologists are already very promising. Also, sometimes the preclinical research and maybe a pilot case look not just promising but exceptionally good. (That was my case.)

In the absense of strong early data, though, yes, phase I trials are more of a gamble than phase II. Phase III are a gamble if you could be randomized to the control group instead of the drug you want to try, so for those you'd at least want to find out if the other treatment will be offered ("cross-over") if you see progression.

Best hopes,

Craig

Reply # - July 24, 2012, 10:08 AM

gn21
Posts: 144

Just a quick post to say that I have now been on the combination for 2 weeks. No major side effects so am tolerating it reasonably well.

In this second stage of the trial there are lots of blood test! I have 10 hours of them next Monday.

Unfortunately I don't think the treatment is doing the job though. The pain under my ribs, which is my indicator, remains. Scans in 4 weeks so I will know then.

Dr is already looking ahead to alimta as next line of treatment.

Gail

Reply # - July 24, 2012, 11:00 AM

certain spring
Posts: 762

Good to hear from you Gail.
Grrrr, is all I am saying. Hope appetite and energy levels still OK.
Glad Bali is before the scans (if I have got the timing right). Holidays are the thing.

Reply # - July 24, 2012, 09:12 PM

Dr West
Posts: 4735

The only thing I'd say is that two weeks is a little early to expect to see much. I don't want to be a Pollyanna, but there's a reason we almost always give treatment for at least 6-8 weeks before repeating scans.

Sorry about the blood draws, a common characteristic of phase I and some phase II trials. Tell yourself you're helping move the field forward (you are).

-Dr. West

Reply # - August 20, 2012, 09:28 AM

gn21
Posts: 144

Well just got results of 6 weeks scan after adding critzonib to the mix. The main tumour has grown from 19 x 26 to 19 x 31. As the doctors say 'not the result we were hoping for'

But all other tumors and possible tumors are stable.

So we go for another 6 weeks and rescan. If there is any growth then I come off the trial and start alimta.

I guess I am at the point of diminishing returns.

But, during the next 6 weeks I have 4 holidays, including 2 weeks in Burma. And I often think that one of the upsides of cancer is that I have been doing the holidays I would have put off otherwise!

Gail

Reply # - August 20, 2012, 09:46 AM

craig
Posts: 330

gn21,

It sounds like either (1) your mechanism of resistance in those spots was not the "MET amplification" kind (which I think accounts for something like 5%??? of Tarceva-resistance in EGFR-driven cancer?), or (b) crizotinib wasn't isn't effective against your version of it.

Is there any way to find out which mechanism of resistance is the one now driving your cancer past the Tarceva (or the Tarceva + Xalkori)?

Best hopes,

Reply # - August 20, 2012, 05:11 PM

blue skies
Posts: 69

Gail,

OK. I am not a medically qualified commenter, but I think it is not out of the question to be glad to see "stability" overall and what looks like a small amount of growth in one site. I will not even attempt to do the math about what percentage growth that 5 cm represents, but (in managing my own reaction if the news were about my own tumor growth), I would likely talk myself into thinking that it might have been worse (my tumors like to "surge") and that I had bought myself some more time with relatively stable results -- giving me more time to find a good next strategy.

Also...I would point out that our friend, Faith and Hope 79, was enrolled in the afatinib/cetuximab trial with essentially stable results like these for 9 months when many of the rest of us had more "shringkage" initially, but progression at 4 months that caused us to leave the clinical trial.AA

I did have an extended period (was it 9 months?) of significant disease response and control with a Carbo/alimta mix followed by Alimta maintenance. From your profile, I would say that you still have LOTS of options and clinical trials left in your took kit.

I hope this gives you a more hopeful vantage point after discouraging news (it's always discouraging when the numbers get bigger instead of smaller or stable). No reason to apologize for that!

Hang in there!

Reply # - August 20, 2012, 10:27 PM

Dr West
Posts: 4735

I'm truly sorry that your results weren't more favorable, though I agree that seeing most of the lesions remain stable is at least a relative victory.

I hope you continue to feel well and that you have a great time on your upcoming planned fabulous travels.

-Dr. West

Reply # - August 21, 2012, 08:31 AM

catdander
Posts:

Hi Gail, I'm sorry it wasn't better news but I agree with others that mostly stable is a "relative victory" .
Know I keep you in my thoughts and ENJOY your HOLIDAYS.
Janine

Reply # - August 21, 2012, 04:19 PM

gn21
Posts: 144

Thanks for your words of support and encouragement. They have certainly helped my in keeping perspective, at a time I needed it!

When I next see dr I will ask about another biopsy to see if we can get any insight into what is going on and maybe assist targeting the demons!

And there is always the hope that with the amount of research being undertaken and frequent nreakthroughs, there will be more options on the horizon when I need them.

In the meantime I will live in the next 6 week block, with 3 holidays!

Gail

Reply # - October 1, 2012, 11:51 PM

gn21
Posts: 144

Just a quick hello from Burma where we have spent the last 2 weeks. A fantastic culture and people, and lots of interesting Americans on our tour of 30 people! Very little Internet access so I am catching up with all the recent Grace posts.

I return to Melbourne tomorrow morning and head straight to Peter Mac for scans. I meet with the dr, Ben Solomon, Thursday morning to discuss the results, which I suspect will not be good.

I will report back then.

Cheers to all

Reply # - October 2, 2012, 12:47 AM

certain spring
Posts: 762

Really glad to hear from you Gail. I was wondering yesterday when your epic travels would be done.
I hope the scans are not going to be as you fear. Hang onto Burma - I find that I now keep hold of these experiences like a dog with a bone.

Reply # - October 2, 2012, 06:14 AM

catdander
Posts:

l like the way you put that certain spring, I've long noted how I tend to hold onto the feeling of being in a special place as long as I can after it's past.
Gail, I'm so pleased you have had a such an interesting experience. Would love to see photos.
I hope you are wrong about the progression.

Hold on to Burma,
Janine

Reply # - October 5, 2012, 09:59 AM

gn21
Posts: 144

Well it was good news and bad news. Had scans Wednesday on the day of my return. Call from dr, your potassium is way too low take some. Ok. Next call 2 hours later, your scans show blood clots in your lungs, return to hospital to start blood thinners ASAP. Ok, done. Next days Appoinment - cancer is stable! Wow, and very unexpected. Finally go home after over 2 weeks away. 30 mins after arriving home, call from dr saying potassium dangerously low, get to local emergency department ASAP for IV. Ok, and then admitted overnight for appox 14 separate bags of potassium as levels slowly, ever so slowly, come back up. Ok, and we'll add two bags for magnesium as well. Blood pressure starts dropping so saline drip.. After much tooing and frying between the hospitals and drs they let me out after 24 hours. Not out the building before phone call saying protein 16, should be minimum of 40, way too low. So no trial medication til we sort it out. In hindsight, other than the blood clots which could have been caused/exasperated by plane travel, I think it's simple. I got sick, stopped eating, and everything fell in a heap. Protein shake for breakfast and no more travel for a while to developing countries me thinks!

But cancer stable - who can ask for more!

Gail

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