Searching for clinical trial - 1250564

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dback
Searching for clinical trial - 1250564

I received my dx of stage IV NSCLC adenocarcinoma in July, 2010. Primary tumor in RUL with mets in left lung, left pelvis and several ribs. A biopsy of lesion in left pelvis confirmed diagnosis and confirmed I was EGFR+
Tarceva was tried as 1st line treatment which provided me with a mixed response for nearly a year. Then, following rather significant progression (additional and enlarging mets in both lungs, mets throughout spine, neck of right femor, and liver), I was switched to Carbo/Alimta for four cycles, followed by once per month Alimta only maintenance for six months until a CT in late September revealed several tumors in lungs had grown larger (but still almost all in lungs are sub-centimeter) and tumor in liver had progress from 8mm to 2.3cm in 4 months. With that evidence of progression, chemo maintenance was halted and I am now searching for clinical trials.
A new biopsy was performed taking a sample from the lesion in my liver. That was sent to Caris for analysis and, according to the report recieved, mutational analysis yielded the following results:
Negative for a BRAF mutation
Positive for a p.L858R in exon 21 of EGFR
Positive for T790M in exon 20
Negative for a KRAS mutation
Indeterminate for PIK3CA
Testing for cMET with FISH showed amplification with a value of 5.91
ALK translocation absent

I have not found an abundance of trials that look like good choices for me. I live in SW Washington state (Vancouver, WA) and would be able to at least consider travel to study sites in or near Seattle, or, more preferably, Portland, Oregon. I have discovered trial NCT01348126 – Ganetespib (STA-9090) + Docetaxel in advanced NSCLC (GALAXY)
One of the available study sites is right here in Portland, OR so would be extremely convenient.
I am looking for, and will appreciate, any help available in selecting a suitable trial.

Dr West
Reply To: Searching for clinical trial

It would be too close to giving medical advice to suggest what clinical trial to do, but I would say that GRACE faculty member Dr. Rachel Sanborn at Providence in Portland has several clinical trials and I believe is activating the compassionate use trial for access to afatinib that might be a feasible option, which I believe would also potentially permit patients to be on Erbitux (cetuximab) (though it would not cover the latter agent, which would need to be paid for by an insurer or out of pocket). Alternatively, my center, Swedish Cancer Institute in Seattle, is opening a trial of an irreversible EGFR inhibitor called PR610 (from the company Proacta) that is thought to be particularly active in a hypoxic tumor environment and could be effective in the setting of acquired resistance. Seattle Cancer Care Alliance may also have a trial for acquired resistance to EGFR mutation positive patients, but I'm not aware of the specific offerings that are currently available there.

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Medical Oncologist
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

certain spring
Reply To: Searching for clinical trial

Good to hear from you, dback, although I am sorry you are in the position of having to look for a trial. However it sounds as if you are well located for some promising options. Best of luck, and keep us posted.

heartspy
Reply To: Searching for clinical trial

Thank you for posting dback and thank you, Dr. West for your response. My 43 year old husband (NSCLC/EGFR Positive/ Mets to bones) has been on Tarceva since 04/12 and his last cat scan on 11/08/12 showed some progression. He started on 150mg and had very positive results, but the side effects were brutal. After lowering his dose to 100mg, his side effects decreased, and his positive outlook increased! He still works everyday, eats well (but is down 25 lbs.), has an amazing attitude and gets much needed rest.
A few options were mentioned and one of them was awaiting a promising trial to surface for acquired resistance pts.While digging around on this site for some answers, I found Dr. Lecia Sequists transcripts noting a biopsy should be done to reveal if there are any new mutations and/or complete mind blowing switches, as in from NSCLC to SCLC!!! The treatment would be different and so would our "trial search". I am hoping to find some updated articles from her or Dr. West, guiding us to more options and/or trials to consider.

winjr56
Reply To: Searching for clinical trial

The available trial sites for the following trial aren't close to you, but the trial itself seems to fit exactly your situation:

http://www.clinicaltrial.gov/ct2/show/NCT01121575?term=c-met+lung+cancer...

More specific enrollment requirements are detailed here:

http://www.clinicaltrial.gov/ct2/show/NCT01441128?term=c-met+lung+cancer...

Crizotinib (PF-02341066) was originally designed as a c-Met inhibitor. Tarceva or Iressa resistance is often via the c-Met pathway, and your tumors now express a c-Met amplification (I assume).

The following study examines Crizotinib and its effectiveness as a c-Met inhibitor (in vitro):

http://www.ncbi.nlm.nih.gov/pubmed/21716144

Dr West
Reply To: Searching for clinical trial

I must confess that I and MANY other oncologists (including many other lung cancer experts) consider the value of a repeat biopsy to be less than staggering. If the progression isn't very rapid, it's extremely unlikely to be SCLC, and there aren't many cases where the findings are at all likely to lead to an "actionable" outcome. It's certainly a reasonable thing to do, but the folks at Mass General and Memorial Sloan Kettering do this mostly because it's the focal point of their research and just what they like to do, not because it's an established standard of care that has any demonstrated effective utility in anything but rare cases. And it's probably worth remembering that SCLC happens to respond well initially to many types of chemotherapy, so even if a regimen specifically for SCLC wasn't used because the biopsy weren't done, the more typical regimens used for NSCLC would also often be a fine choice.

Here's some additional discussion of thoughts on managing acquired resistance to targeted therapies:

http://cancergrace.org/lung/2012/08/05/acquired-resistance-faq/

Good luck.

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Medical Oncologist
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

certain spring
Reply To: Searching for clinical trial

Hallo heartspy. I'm glad your husband is doing so well.
I don't think we've had anything substantial from Dr Sequist on GRACE since that discussion of repeat biopsies.
I am sure you have found them in your search, but just in case you haven't, Dr West has written some interesting posts on sticking with the Tarceva or targeted agent beyond progression:
http://cancergrace.org/lung/2012/06/09/ar-local-rx/
http://cancergrace.org/lung/2012/06/19/chemo-with-or-without-ongoing-egf...
He also reported recently on some startling results in a trial for Nexavar, which showed unexpectedly good survival in EGFR positive patients:
http://cancergrace.org/lung/2012/10/17/mission-trial-neg-egfr-mutn-pos/
We also have a thread that might interest you:and others who are posting here:
http://cancergrace.org/topic/egfr-tki-and-acquired-resistance/page/2
At the start of that thread, there is a link to a previous thread on the old site, which contains a lot of discussions about trials etc that you might find useful:
http://cancergrace.org/lung/topic/acquired-resistance-to-egfr-tki/page/7/
Best to you and your husband.

heartspy
Reply To: Searching for clinical trial

Thank you for the clarification, Dr. West. I surely misinterpreted Dr. Sequist's findings and/or did not investigate thoroughly. Maybe, we will find ourselves visiting The Swedish Cancer Institute in Seattle for that PR610 trial or another. We live at the opposite end of the country in Naples, FL. - but, that wouldn't stop us!
Certain Spring: Your post is very much appreciated. By following a former post of yours, I had already read about Nexavar and do plan on discussing with his Oncologist. The links above do help navigate this site in a timely fashion.
So grateful to all who share, the "never alone" feeling merits it's own healing power.

certain spring
Reply To: Searching for clinical trial

Just looking at the trial mentioned by winjr56, and I think it's the one that GRACE member gn21 is on in Australia. You can follow her progress here - some of the side effects have been very tough:
http://cancergrace.org/lung/topic/clinical-trial-nct01259089/
(the actual trial no. is NCT01121575!)
Heartspy, one other thought which I am sure you have pursued is afatinib, or afatinib/cetuximab. Geographical knowledge of the US is not my greatest asset, but there are sites in Florida for the afatinib "expanded access scheme" that Dr West mentioned above:
http://www.clinicaltrials.gov/ct2/show/study/NCT01649284
I don't think you misinterpreted Dr Sequist's research at all - I think it's more a question of how useful it is in practice for the average patient to have a re-biopsy, ie what do you do with the information when you've got it? For a motivated patient who has access to a major research centre like MGH that runs clinical trials, and who can have a biopsy done without too much discomfort or risk, I think it's a reasonable option to consider. But that's a lot of "ifs". I for example would willingly have a re-biopsy if I was in a fit condition on progression, but would not hold out much hope of persuading anyone that it was worthwhile doing one. I also suspect (and this as I understand it is Dr West's point), that it wouldn't make much difference to the treatments I am likely to be offered.

catdander
Reply To: Searching for clinical trial

Certain Spring I think you've added a good explanation to help fill in the blanks.

CS your right too about your geography. Florida and Oregon couldn't be much further apart in the contiguous US. But Oregon and Washington state share a border. So Dr. Sanborn in Portland, Oregon may be able to offer compassionate use of afitinib and Dr. West at Swedish in Seattle Washington can certainly offer a wonderful consult.

Just in case of an Alabama/Florida geo quiz question. We share a border. :wink:

certain spring
Reply To: Searching for clinical trial

It is true I have no sense of direction but it is not as bad as that!
heartspy said she's in Naples, Florida. My link was to the expanded access afatinib scheme, which has sites in Florida as well as in Portland, Oregon. These sites are in - Hollywood, Jacksonville, Lakeland, Orlando and Port St Lucie.
Believe it or not I have actually been to Portland, Oregon, so I know where it is. Very nice too.
Anyway, why should I know this stuff? I bet none of you could find the way to Kirkintilloch :)

heartspy
Reply To: Searching for clinical trial

Haha, Certain Spring, not only could I not find my way, I can barely pronounce Kirkintilloch! Thanks for all your input. Still reading/researching. :)

catdander
Reply To: Searching for clinical trial

Oh good grief. I must admit I was a bit surprised.
Of course I know my way to Kirkintilloch, I have google maps for Petes sake. Hehe :)

dback
Reply To: Searching for clinical trial

Sorry for taking so long to express my gratitude.
Thank you Dr West, and all others, for responding and/or contributing to this discussion.
So far I am "striking out" finding a trial that works. In several cases I have been disqualified based on having had too many prior treatments (even though I have only completed 2 lines (including Tarceva as 1st line)
Dr. West, you mentioned that your center, Swedish Cancer Institute in Seattle, is opening a trial of an irreversible EGFR inhibitor called PR610. Do you have any idea when that will open or who I may contact for further informarion. Could I expect exclusion due to my prior experience of having been on Tarceva?

Thank you

heartspy
Reply To: Searching for clinical trial

Hi dback- we arestill searching, also. Something I stumbled upon is by Clovis Oncology/ Drug CO-1686. I am considering Mass General, as we are on the east coast, but same clinical trial is being held at UCLA, Stanford, University of Colorado and Karmanos, MI. - no idea if you or my husband fit the criteria, but have contacted MGH for further info. this morning and awaiting response. Have you checked out: www.clinicaltrials.gov - they have listing all around the country. I know close to home would be better for support/ less stress. Hopefully, Swedish Institue's PR610 is a go for you! Rooting for you and the Miracle! Keep expecting/ Keep Believing!

Dr West
Reply To: Searching for clinical trial

The PR610 trial is probably, hopefully just a few weeks away, but you can call the Swedish Clinical Research Office, perhaps Desiree at 206-386-2443, to get information about time lines and initiate a process of getting connected in anticipation of the trial being activated. The trial is for patients with acquired resistance to EGFR inhibitors like Tarceva (erlotinib), so I'm almost completely certain that prior treatment with Tarceva won't be an exclusion criterion, and I think patients who have received a few lines of prior therapy are eligible (in fact, I don't think there is any exclusion based on the number of lines of prior therapy).

Good luck. I'd be happy to offer you the trial here if I can.

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Medical Oncologist
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

heartspy
Reply To: Searching for clinical trial

This is good news, Dr. West! Thank You!
dback if you are looking for more information on PR610: http://clinicaltrials.gov/ct2/show/NCT01631279
Wishing you the best, Sir.