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FOR ALL ON CLINICAL TRIALS (edited name)

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FOR ALL ON CLINICAL TRIALS (edited name)

Postby dianne052506 » Thu Jan 03, 2013 1:40 pm

January 18, 2013
Three weeks ago, I started this thread to update news on my progress in a clinical trial. Others have asked that this be made into a more general thread about clinical trials, hence the name change. Some of us are lucky enough to have oncologists who share, without prompting, information on clinical trials. Some of us actually have to go around our own doctors to find something else to try. It shouldn't be that way. To paraphase my own doctor: Without the clinical trials, all of today's drugs would not exist. How can new drugs be developed when it is so hard to get into a clinical trial? Oddly enough, he doesn't necessarily place the blame at the foot of the government as some might expect. He faults the difficulty is spreading information - to the patients as well as to the oncologists themselves.

Some patients, like myself, look for clinical trials when all other chemo has failed them. To me, the really brave ones are the ones who choose clinical trials instead of the already approved, proven drugs. Those patients are so important in the testing of a new drug, and so hard to come by.

If you have taken this uncharted fork in the road and have chosen a clinical trial, this thread is for you. If you're just considering one, join right in, too. No one here necessarily has answers, but we're looking hard, sharing connections that might help someone else. To all, please feel free to add thoughts and comments.
dge


1/3/13
I started this phase 1 trial http://clinicaltrials.gov/ct2/show/NCT01633970 in August. I get an infusion of the study drug plus Avastin every 3 weeks. Today was round 7. I have a CT scan before every odd-numbered round. Today I got back the report from the 3rd scan since the baseline one. I am thrilled to report that I got good news for the third time.

On the scan before round 3, everything was stable. On the scan before round 5, some slight shrinkage was noted, one of the marker nodules was down about 15% by my calculations of the measurements. Today's report showed one of the marker nodules down 70% in size, and some others that appeared stable in size showed signs of cavitation.
Conclusion: "Stable, with slight improvement."

When I started this trial, I had 20-30 nodules scattered across my lungs. Only a few were larger than 1 cm, making changes difficult to note, unless they are signigicant. I cannot be called an official "responder" to the study unless I show 30% shrinkage when the total tumor burden is measured. With all these small nodules that might be difficult. Dr. P. tells me that patients with larger tumor burdens tend to show results earlier, so he is very pleased that I am showing any improvement at this point. I will celebrate big time if/when I am a "responder," but for now, I am very, very, thankful to be "Stable, with slight improvement."

This study is immune system therapy, attempting to get the patient's immune system to recognize the tumor as something it should fight. The side effects have been very minimal, just a general run-down feeling. Compared to my 5+ years with oxaliplatin and irinotecan, this really is no big deal.

The only downside to this trial is that it is offered in so few locations across the country, making it very difficult for most patients to consider it. If there is any hope with this drug, I want so badly to be able to share it with my friends. I feel guilty for feeling half-decent these days, especially when we have lost so many friends this past year, and right now, so many are out of options and losing hope.

There is another trial http://clinicaltrials.gov/ct2/show/NCT01375842 with this same study drug as a single agent. It is offered in a few more places across the country and in Europe, but still not exactly convenient to a lot of people. Dr. P. did say that the sponsor particularly wants CRC patients for this trial, but it will only be open a few more months. If anyone even thinks there might be some interest, he/she should contact one of the trial centers right away.

Today, I am very thankful for the time I have been given - time I certainly didn't expect. My daughter was 9 when I was diagnosed. She turned 16 this week.
I am also saying a prayer of thanksgiving for all my friends here, and praying for comfort for all those touched by this awful disease.
Dianne
Last edited by dianne052506 on Fri Jan 18, 2013 12:27 pm, edited 1 time in total.
May 06 Stage IV CC: liver,ovarian mets
Oct 07 inoperable lung mets
Feb 08 - Apr'12 chemo
allergic to oxaliplatin, irinotecan
Aug '12-Feb'14 Genentech PD-L1/Avastin trial
Mar '14 -radiation to largest lung nodule
still recovering; looking at trials again
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Re: Clinical Trial - PROGRESS REPORT

Postby jgall » Thu Jan 03, 2013 1:53 pm

Diane! this is SO exciting to hear. As you know (since we PMd about it), my DH's onc is VERY interested in this study. I'm hoping that he's considering getting involved and may somehow bring it here and have it open to more people since we're at such a large cancer center.

I'm thankful DH doesn't need it yet, but it's good to know there are things on the horizon that are so promising. As you know, we never know when things could change. When we saw Dr. G last, he remarked how it is actually quite remarkable that Iri/Erbi are still working for my DH two years later, and since all 5FU based drugs are out of consideration for us, and Regorafenib doesn't seem to hold too much promise (IMO), I am keen on this one!

Thank you not only for doing the study, but also for keeping us appraised of your results. I've got all my fingers and toes crossed for you...even my eyes! :)

Julia
DH Chris, 50, Dx Nov '10 Stg 4
cardiac arrest from 5-FU
Iri/Erbi
7 '11-RFA
8 '11-liver/colon resection
NED
2 '12 recurrance
6 '12 chemo break
11 '12 back on chemo
http://www.caringbridge.org/visit/chrisandjulia
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Re: Clinical Trial - PROGRESS REPORT

Postby Maia » Thu Jan 03, 2013 2:05 pm

Ahhhhhhhhhh.. So HAPPY to hear this! It was thinking past night about how you're doing and also how was Skypup doing!
My friend had some bad news recently (brain met, I posted about it here viewtopic.php?f=1&t=38714 ); I was looking for an immunotherapeutic approach for her, before this --now I'm even more interested.
I'm so thrilled for you, Diane. You made my day!
Enjoy "improvement", let the adjective aside! :D
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Re: Clinical Trial - PROGRESS REPORT

Postby crazymotherof8 » Thu Jan 03, 2013 2:09 pm

Dear Diane,
Thank you so much for posting today. We got to our cancer center here in az and hubby's tumor markers are way up and so Folfiri + Erbitux is officially done. Onc suggested clinical trials at TGen here in Scottsdale. I opened your link to the single arm trial and it is here in Scottsdale! :) will definitely check it out!!
Niki
DH Matt - 49 - father to 8
Dx Mar11 w/Mets to liver, lungs Folfox + Avastin Mar 11 - Jul 11
Sept11 Spleen remvd bc low platelets
Oct12 Folfox+Avastin
Mar12 Folfiri+Avastin
Aug12 bone mets; irinotecan+Erbitux
Dec12 chemo failed - trial
passed June 17, 2013
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Re: Clinical Trial - PROGRESS REPORT

Postby dianne052506 » Thu Jan 03, 2013 2:10 pm

Julia, when these two phase I studies are finished, Dr. P. tells me that phase II trials will be for patients who have never had treatment for their cancer. Can you imagine, being brand-new in Cancer World, and a doctor asking you to consider a study rather than conventional, already-approved treatment? In hindsight, this drug vs all the side effects of oxaliplatin and irinotecan, I would easily say yes. But in the fog and panic of a new Stage IV diagnosis, I just don't see how many patients would be brave enough to do that.

Best wishes to you and DH,
Dianne
May 06 Stage IV CC: liver,ovarian mets
Oct 07 inoperable lung mets
Feb 08 - Apr'12 chemo
allergic to oxaliplatin, irinotecan
Aug '12-Feb'14 Genentech PD-L1/Avastin trial
Mar '14 -radiation to largest lung nodule
still recovering; looking at trials again
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Re: Clinical Trial - PROGRESS REPORT

Postby dianne052506 » Thu Jan 03, 2013 2:14 pm

Maia - I read about your friend's difficult news. I am so sorry. I hope you are able to find something to try next.

Niki - I'm sorry your DH didn't get good news, but maybe Scottsdale wil work out. I hope the doctor in AZ is as gentle and compassionate as Dr. P. is here is North Carolina. I have been truly blessed with doctors I like.

Dianne
May 06 Stage IV CC: liver,ovarian mets
Oct 07 inoperable lung mets
Feb 08 - Apr'12 chemo
allergic to oxaliplatin, irinotecan
Aug '12-Feb'14 Genentech PD-L1/Avastin trial
Mar '14 -radiation to largest lung nodule
still recovering; looking at trials again
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Re: Clinical Trial - PROGRESS REPORT

Postby usopen » Thu Jan 03, 2013 2:20 pm

Dianne, i know you know how great this is to hear. Thanks for the update.
I hope you got to nyc with your daughter for some well deserved fun. You've been at this a long time.

Joan
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Re: Clinical Trial - PROGRESS REPORT

Postby Maia » Thu Jan 03, 2013 3:00 pm

dianne052506 wrote: Dr. P. tells me that phase II trials will be for patients who have never had treatment for their cancer. Can you imagine, being brand-new in Cancer World, and a doctor asking you to consider a study rather than conventional, already-approved treatment? In hindsight, this drug vs all the side effects of oxaliplatin and irinotecan, I would easily say yes. But in the fog and panic of a new Stage IV diagnosis, I just don't see how many patients would be brave enough to do that.


Wow, Diane, in some aspects, that would be my friend --she has CRC since 2006 but only had surgeries as treatment (2006, 2009), until this past May 2012, when she did only capecitabine. Right now, she had brain surgery, but she didn't started radiation yet. I see "active CNS metastases" is an exclusion criteria, but she didn't have any 'active', right now. My friend is in Canada, but a very good friend of her lives in Apex, North Caroline -I'm getting that that is near Durham. The other NC location is Huntersville... Is your Dr P in Durham or Huntersville, if I may ask?
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Re: Clinical Trial - PROGRESS REPORT

Postby smokeyjoe » Thu Jan 03, 2013 3:20 pm

This is very interesting!!! Thank you for posting and taking part in this clinical trial, so good to hear your having good results :) When I was first diagnosed and when I went for my very first appointment with my oncologist he brought up clinical trials, he had already checked to see if he could get me into one ..... I was completely shocked first by his news I was stage 1V and incurable and that he was suggesting a clinical trial in that same appointment!!! I didn't qualify because I had blood clots in my lungs...talk about shell shocked. I didn't even know what a clinical trial was .... let alone what my cancer treatments would be.
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Re: Clinical Trial - PROGRESS REPORT

Postby Laurettas » Thu Jan 03, 2013 3:50 pm

So excited for you Diane. Hope that the news will continue to be very good for you and eventually hopefully a lot of other people with this DAMN disease. Please keep us posted as this is great news!
DH 58 4/11 st 4 SRC CC
Lymph, peri, lung
4/11 colon res
5-10/11 FLFX, Av, FLFRI, Erb
11/11 5FU Erb
1/12 PET 2.4 Max act.
1/12 Erb
5/12 CT ext. new mets
5/12 Xlri
7/12 bad CT
8/12 5FU solo
8/12 brain met
9/12 stop tx
11/4/12 finished race,at peace
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Re: Clinical Trial - PROGRESS REPORT

Postby Kathryn in MN » Thu Jan 03, 2013 4:10 pm

This sounds promising! I'm glad you are stable with shrinkage!

I'd like to do something like this, but the particular trial is out for me right now. There are no locations near me, and as far as I know, I don't have much to measure by CT as far as active tumors. I have something odd going on with T2 (as seen on MRI), and a .5cm tumor at T5 - both in my spine. No nodes are enlarged anymore. I haven't had a PET scan since August and that is what normally picks up my tumors. My last CEA was normal. But I KNOW I have cancer cells in my body still. Right now would be the time to kick my immune system in to attack them so they cannot grow again.

I hope you continue to have good results and can keep going on this drug even if they move on to Phase II trials.
CRC AUG09 Age 47
Sig Res T4a N2a Mx, KRAS mut codon13
Mets bones & nodes
FOLFOX, FOLFIRI, Avastin, Radiation
Irinotecan, Zaltrap & STAR RFA
APR13 pleurisy & ascites - more chemo & draining
http://www.caringbridge.org/visit/kathrynblume
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Re: Clinical Trial - PROGRESS REPORT

Postby SoConfused » Thu Jan 03, 2013 4:11 pm

Congratulations! that's fantastic news ... so happy for you. And so thankful for Genentech - they're definitely at the forefront of cancer research and behind many of our current weapons against this awful disease.
Stage IV CC
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Re: Clinical Trial - PROGRESS REPORT

Postby sharonr » Thu Jan 03, 2013 4:15 pm

Speaking for a past caregiver, it is wonderful to hear that you are having success. For those that knew Brady, he was willing to try anything and report on the results in hopes that it helped someone. Best of luck with the trial and I do hope you become a responder. For you old timers that are still out there glad you are, there has been a loss of some special people this year, and yes I do come and check on Brady's friends on occasion.
Bradyr's wife
DX 2/07 mets liver/bone/brain/spleen
Foxfox/avastin 3-6/07
xedada 9-7/07
Folfri 1-6/07
GammaKnife brain lesion 1/08
SIRT Spheres rlobe 7/08 llobe 8/08
cyberknife brain 10/08
Brain surgery 1/09
Vebctibix 1-4/09
Passed Away 5/21/2009
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Re: Clinical Trial - PROGRESS REPORT

Postby Dsod » Thu Jan 03, 2013 4:55 pm

Thank you for posting your report. This is a very interesting trial and it will be good to see if it makes a real difference.

Donal
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Re: Clinical Trial - PROGRESS REPORT

Postby Maia » Thu Jan 03, 2013 5:02 pm

sharonr wrote: For those that knew Brady, he was willing to try anything and report on the results in hopes that it helped someone.


Sharon, so glad to 'meet' you. I can't believe the coincidence.. I posted this for you yesterday viewtopic.php?f=1&t=38714#p276657
I feel like if I knew Brady : )
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