Re: LY2801653 clinical trial

End of cycle 3 and results are in... CA19-9 is NORMAL!! 35.7!! Weight is still climbing. Doc is happy! So am I! My new clothes are upset, but that's life.
No ct this round so have to wait another 4 weeks to find out, but everything points to stability and inactivity.
Onc gave me a prescription for my face and its better. I've been washing my hair with Selsun Blue and the scalp is better, too. Still have some pimply itchy things, but nothing like it was. I also went back to washing my hair almost every night. I have been trying to do every other day for the past 5 years, but I guess my new skin type says "CLEAN"!! So I will!
The swelling is better, too. Still swollen in morning... Enough to change the fingers of my rings, but after a couple of hours, they are back to normal.
I will take these minor discomforts any day!

KrisJ
"Don't just have minutes in the day; have moments in time."
Any opinions I give are based on personal experiences, and are not based on medical knowledge. I strongly suggest receiving medical care and opinions.

Re: LY2801653 clinical trial

Wonderful news. So happy for you. I look forward to many great updates.

Way to go.....
Carl

Re: LY2801653 clinical trial

Yay!!! Great news Kris! Looking forward to hearing more good news from you as well!

Any advice or comments I give are based on personal experiences and knowledge and are my opinions only, they are not to be substituted for professional medical advice. Please seek professional advice from a qualified doctor or medical professional.

Re: LY2801653 clinical trial

Kris....excellent and exciting news.  I am thrilled for you.
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: LY2801653 clinical trial

That is great news , I hope you all the best.
Any idea about approval cycle for those medications which I hope will work for the benefit of humanity and every great member of this website?

Re: LY2801653 clinical trial

Hi,

Here may be your possible answer.

http://clinicaltrials.gov/show/NCT01285037

God bless.

Please know that my personal opinion is not intended nor implied to be a substitute for professional medical advice. If  provided, information are for educational purposes.Consult doctor is a MUST for changing of treatment plans.

32 (edited by kris00j Mon, 29 Jul 2013 10:08:26)

Re: LY2801653 clinical trial

I don't know when this will go to phase 2. They are not getting a full allotment of cc patients. I think they had 5 people last month. And one had to leave the study due to health issues.
I myself am having a great response to this. The cancer cells are stable and my blood work is wonderful! They check kidney functions, too. No probs. the only issue is a slight effusion at the bottom of my heart. We are watching that.
I'm hoping there's enough data to continue this and possibly get to phase 2 soon.

KrisJ
"Don't just have minutes in the day; have moments in time."
Any opinions I give are based on personal experiences, and are not based on medical knowledge. I strongly suggest receiving medical care and opinions.

Re: LY2801653 clinical trial

An update on the trial: I am 6 cycles in. A cycle is 28 days. I just had another CT Scan and there is shrinkage! It is 4mm smaller. That's great news since the drug is built to stabilize the cells! And the CA19-9 is lower again! I'm in the "normal" range! Yeah!
The side effects are... I've begun losing my hair, but I still have tons left. I was worrying about going bald, but have decided to stop worrying. And my left ankle area is swollen and does not go back down. That's it. I'm extremely happy with this trial!!

KrisJ
"Don't just have minutes in the day; have moments in time."
Any opinions I give are based on personal experiences, and are not based on medical knowledge. I strongly suggest receiving medical care and opinions.

Re: LY2801653 clinical trial

You normal, NEVER! Oh you mean with the Trial and CC! HA, HA
That is such good news I have had good feelings about this since the get go. I am so over the moon for you, you know that. Think I will celebrate YOU tonight! Love you!

Teddy ~In our hearts forever~ATTITUDE is EVERYTHING
Any suggestion I offer is intended as friendly advice based solely on my own experience. Please consult your doctor for professional guidance.

Re: LY2801653 clinical trial

Lainy, I am NOT normal! That's why I put things in quotes!! lol

KrisJ
"Don't just have minutes in the day; have moments in time."
Any opinions I give are based on personal experiences, and are not based on medical knowledge. I strongly suggest receiving medical care and opinions.

Re: LY2801653 clinical trial

Fantastic Kris!  So happy for you.

Wishing all God's blessings!

Re: LY2801653 clinical trial

Wow, that's wonderful!!  Do you know about how the rest of our "kin" are doing on the trial?

Enjoy chemolessness!
Regina

Re: LY2801653 clinical trial

I actually don't know about cc patients, but I have met with a couple of the colon(?) cancer patients, and except for dehydration because she won't drink enough, we all seem to be doing well.
I have met cc patients, but their numbers weren't good enough for the trial. I don't understand that. If someone is sickly but wants to attempt the trial anyway (due to lack of options) I think they should be allowed to be a guinea pig to see if it would reverse the progression in severe cases. But the drug companies call the shots.

KrisJ
"Don't just have minutes in the day; have moments in time."
Any opinions I give are based on personal experiences, and are not based on medical knowledge. I strongly suggest receiving medical care and opinions.

Re: LY2801653 clinical trial

Kris,
You are a brave pioneer for all who dream of stopping CC in its tracks.  God definitely has special plans for you! Congratulations on yet another fabulous update:)

Willow

Re: LY2801653 clinical trial

Us patient advocates working in the NCI clinical trial setting are very much aware of the rulings set forth in re: to clinical trial adherence.  Phase I clinical trials determine the toxicological effect on generally healthy people. It would be difficult to determine whether the adverse effects are related to the ill health of the person or whether it would represent a side effect of the medication.  Additionally and most importantly though, humans must be protected in research studies.  Phase I clinical trials are designed to measure the toxicity or side effect of a drug because, at this point, no one knows what is too much and how much can a person handle.  Due to the abuse of humans in research studies the HUMAN SUBJECT PROTECTIONS guidelines were put in place. The pharmaceutical industry has to abide by the rulings as does everyone else conducting clinical trials.  The FDA will not approve a clinical trial unless strict adherence to the guidelines is practiced. 
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: LY2801653 clinical trial

Thanks, Marion. It's just too bad that people who are "sick" and running out if options can't be in most of these trials. I mean, what do they have to lose? I understand the reasoning, but I just wish there were an "invisible" test group.

KrisJ
"Don't just have minutes in the day; have moments in time."
Any opinions I give are based on personal experiences, and are not based on medical knowledge. I strongly suggest receiving medical care and opinions.

Re: LY2801653 clinical trial

So true, Kris, everyone should have the opportunity to enter a clinical trial.  First and foremost, Clinical trials are “research studies” which determine a drug efficacy via Phase I through Phase III and the ongoing Phase IV studies.  This is it in a nutshell.
Secondly, patients may or may not benefit from the clinical trial.  This is especially true for Phase I studies for the reason mentioned above.  I agree with you in that everyone should be given a chance to better his/her situation.  But there has to be some regulation put in place in order to protect those desperately trying to find answers to their illness.

To recap:  Clinical research studies are designed to help future patients, but also may be beneficial to the current patient population.  The absolute fantastic news is that the currently mentioned Phase I trials on our site have shown to be extremely beneficial to numerous people including you.  And, how much better can it get?
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: LY2801653 clinical trial

They are expanding this trial... Phase 2: New study pairing it with cisplatin. I don't know if it will be offered elsewhere... I am unable to participate in this for at least 6-12 months. We shall see how the pairing works first. My oncologist doesn't understand the drug choice since cisplatin is never administered alone.
I met someone today with colon cancer that tried this trial at Phase 1, and it did not work. He gas moved to another trial, which is giving him bad reactions. I feel so bad for him, and wish I could do something...

KrisJ
"Don't just have minutes in the day; have moments in time."
Any opinions I give are based on personal experiences, and are not based on medical knowledge. I strongly suggest receiving medical care and opinions.

Re: LY2801653 clinical trial

I heard today that the Phase II has started. It is being paired with Cisplatin. BUT the entrance rules have changed. Now you must have only had one path of treatment. So even I am not eligible for Phase II!

KrisJ
"Don't just have minutes in the day; have moments in time."
Any opinions I give are based on personal experiences, and are not based on medical knowledge. I strongly suggest receiving medical care and opinions.

Re: LY2801653 clinical trial

Kris, BOO! Do they give any suggestions for what could be next?

Teddy ~In our hearts forever~ATTITUDE is EVERYTHING
Any suggestion I offer is intended as friendly advice based solely on my own experience. Please consult your doctor for professional guidance.

Re: LY2801653 clinical trial

Lainy, I just reread this: it is misleading! I am still in phase 1. I would not be eligible for phase 2! I don't know if I could change to phase 2 if it proves even better. But since all is great here, I don't know that I would want to!

KrisJ
"Don't just have minutes in the day; have moments in time."
Any opinions I give are based on personal experiences, and are not based on medical knowledge. I strongly suggest receiving medical care and opinions.

Re: LY2801653 clinical trial

Kris... Part D consists of dose determination for LY2801653 in combination with cisplatin in participants with cholangiocarcinoma followed by an expansion cohort. •Part D - Diagnosed with cholangiocarcinoma and have not received more than 1 prior systemic therapy.

There still is the option of below. 

25mg/m2 Cisplatin given via IV infusion once a week for 2 weeks and then every 3 weeks. If the LY2801653 is terminated for LY2801653-related toxicity after a minimum of 4 cycles, Cisplatin may be continued as monotherapy until progression of disease. Participants discontinuing Cisplatin therapy may be allowed to continue single agent LY2801653 if they are receiving clinical benefit.

It clearly states that LY2801653 will be halted if and when toxicity to drug presents after a minimum of 4 cycles. Only then monotherapy with Cisplatin can be administered until disease progresses.  In that case, LY2801653 can be used again. 

Seems that options are available.

Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: LY2801653 clinical trial

Hmmm. I haven't had toxicity problems, as far as I know. So that's good! And I just started cycle 10. I'm perfectly happy with it so far.
I thank you for the further info which I was unaware of. I'm hoping some members may be able to benefit from this trial, too.

KrisJ
"Don't just have minutes in the day; have moments in time."
Any opinions I give are based on personal experiences, and are not based on medical knowledge. I strongly suggest receiving medical care and opinions.

Re: LY2801653 clinical trial

Kris...the additional treatment arms must have been released just recently.  Phase I trials are designed to determine the toxicity level tolerable to humans.  Based on data not yet released and/or accumulated, phase II and Phase III trials are designed. 

Part D of this trial is to establish how much LY2801653 can be tolerated when combined with another drug, Cisplatin.  At this point, no one has the answer.   Hence we call it: clinical "research" studies. 
Ideally, these types of studies are conducted on people never exposed to toxins of any kind.  But, obviously, this is not possible.  The next, best alternative is to recruit people with no prior treatment. That often is not possible, because life threatening diseases such as ours, are aggressively attacked with drugs or radiation, which in turn cause molecular changes within the cancer cells.
The investigators of this study work closely with the pharmaceutical company providing the drug.  Based on their combined data, LY2801653 and Cisplatin can be administered to those with one prior chemotherapy regimen (not more) and still reveal acceptable new data for this drug combination in re: to acceptable toxicity levels of LY2801653.

But for you, things are different. You may continue on to cisplatin and LY2801653 or eliminating LY2801653 due to toxicity levels or the cisplatin for other reasons or, you may very well stay on LY2801653 indefinitely.

You are doing so incredibly well and that is simply fantastic. 

Hugs
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: LY2801653 clinical trial

And I thank God for that!! I don't know if you would recognize me anymore... Now when I smile it actually reaches my eyes! smile
I even get to lose 1 visit day now! Every 4 weeks I've been going in Day 28 (or close) and day 1. Now I get to skip day 28 on my non-ct scan cycles! That means I'm down to 3x in 8 weeks!! Joy!
If I had known, my flight home would have been a different day! Oh, well...

KrisJ
"Don't just have minutes in the day; have moments in time."
Any opinions I give are based on personal experiences, and are not based on medical knowledge. I strongly suggest receiving medical care and opinions.