February 3, 2016 at 6:07 pm #91246
For Julie, Porter, Marion, Catherine and Melinda –
I appreciate all your well wishes and I’m sorry I didn’t see these posts sooner! It’s been a crazy hectic couple of weeks, but Julie, you are totally right: we are doing something now instead of waiting/feeling useless and even instead of constantly researching. We’ve handed the reigns over to God, to fate, to the potential of this drug to become FDA approved and to work for many people with ICC!
It was a very personal decision to go with a trial first instead of chemotherapy, but the fact that they accepted Tom (and within a day’s time!) makes me believe that they believe the drug will work and that it was the right decision.
We continue to be amazed and encouraged by this site, by the doctors and nurses at Emory and all the survivors out there as well as the trial participants (none of whom we have met).
Porter, that is so wonderful that you are NED! Like I said in another post, I sincerely think the BGJ-398 is similar in chemical makeup to the ARQ-087 – just 2 different drug companies (Bayer [or is it Novartis?] vs. Arqule). If it’s actually all 3 drug companies, you know they are on to something good.
Same side effects for both drugs (from what I’ve read on here and on Tom’s consent form) and the big worry, of course, is kidney function, but they almost take better care of you and see you more often whilst on a trial because they want to make sure the drug is not doing any harm. I am surprised that they wait 5 weeks before doing the follow up CT scan to see where the disease is. I wish we could know exactly when the drug starts to work! It’s a little risky but at this point we are okay with the risk. Whether you choose the trial sponsored by Bayer, Arqule or Novartis, I think they are all 3 comparable due to the targeting of a mutated gene.
I’ve created a post under Clinical Trials and will keep it up to date, I promise.
Hugs and love to you all!January 29, 2016 at 2:02 am #91245pfox2100Member
Ashley, I too have the fgfr2 mutation. Currently I am NED but we are looking at a few suspicious lung nodules right now that they hope to biopsy in a couple weeks. We won’t know our plan of action until we get those results but..we have talked about if it is cc, I would start chemo again before trying to get into a trial at MD Anderson. I believe mine is a phase II-BGJ398 (it sounds like the one Tom will be on is different) and I am wondering if I should also look more into this for when my time comes and want to look into as many options as possible.
I am glad to hear he got accepted into the trial and too look forward to hearing good results. Hugs and prayers to you.
PorterJanuary 27, 2016 at 2:20 pm #91244iowagirlMember
Ashley, Congratulations to you and Tom on his getting into the trial. You are a wonderful caretaker and wife. I love that you have taken it upon yourself to be the researcher so that he can have some downtime after his job and enjoy life. Don’t forget about yourself though. I know that you just want him around longer and would do anything to achieve that though……I get that. But the love you have for Tom is very apparent and you’d do anything to protect him and keep life as normal as possible for him. I look forward to hearing good results posts. Now that you’re on the trial, it probably feels different. That’s because you’re doing “something” and have a “direction” to go with treatment. Again…congratulations and best wishes.
Julie T.January 27, 2016 at 11:26 am #91243middlesister1Moderator
I’m very excited for you and Tom. Best wished for huge success with the trial. Looking forward to hearing encouraging results!!!!!
CatherineJanuary 26, 2016 at 11:12 pm #91242
Ashley….happy to hear that Tom has been accepted and that you had a great experience with Emory. The study is accruing 120 people within their numerous locations; I think that it is a feasible goal.
BTW: this is the study: https://clinicaltrials.gov/ct2/show/NCT01752920
I wish you the best of luck, safe travels to and from Atlanta, and I await your reporting of spectacular results.
MarionJanuary 26, 2016 at 9:05 pm #91241
Great News! I’ve been so busy that I haven’t had a chance to post the outcome of Tom’s screening for this clinical trial, but he has been accepted and we are over the moon happy!
Tom has to go to ATL every Friday for 5 weeks straight and then the visits will level off from there if all goes well. He starts this Friday and we are way too pumped about a long car ride to and from in one day. Haha.
I think this will be such a good experience and something so radical and different from standard line treatment! He starts at 300mg daily. Will be very interesting to see how things go and if the drug helps shrink his tumors. Still waiting on results from the scan he had last week – it’ll be good to see just what we’re dealing with this late in the game without any treatment thus far.
Regardless, the staff at Emory have been wonderful to us and I think they are just as excited as we are – basically they were clamoring for Tom to be in this trial because I don’t know if they had enough volunteers to warrant it effective. I think they said there were 20 participants overall.
I should probably start posting in the clinical trials section now so I can get some input on side effects with this type of drug and see how everyone involved in trials is fairing.
Here is to possible longer life extension!
It hits me sometimes that my husband of only two years may not be around very long, but I’m trying to think positively and all the stories on this site have been so inspirational to both Tom and I. I’m kind of the go-between because he has a very demanding full-time job and I’ve assigned all research and work to myself so he can relax and rest during his down time and so he can enjoy the things he likes the best.
Either way, he’s in great spirits and we are counting the days until Friday!
Thank you to everyone who has responded to my initial post and look forward to speaking with all again soon!
AshleyJanuary 25, 2016 at 10:18 pm #91240mbachiniModerator
Thank you and thank Tom for me. I appreciate your willingness to participate in a trial. My attitude was and still is at this point, “I have nothing to lose, and everything to gain!” ……that is just how I felt when I entered into the clinical trial. ….being stage IV, and having gone through so many treatments. Please keep us updated and I look forward to hearing great results!
MelindaJanuary 21, 2016 at 4:52 pm #91239lainyParticipant
Dear Ashley, I am crossing everything I have that Tom gets his approval for the trial!! The whole idea is to do what ever it takes to keep on keeping on until that Divine Intervention takes place to cure CC. We have come a long way in 10 years and we just feel that time is around the corner. Hoping for you to get the positive phone call!January 21, 2016 at 4:21 pm #91238
Thank you Melinda for your response! I have such deep respect for your battle with this horrible cancer. You’re beating the odds and that is amazing. Such inspiration to me considering having only been married 2 years (just!) and not wanting to lose my husband so quickly. I’m so thankful for you and so many others just like you that contribute your experiences and opinions to this board.
Yesterday we went to Atlanta to Emory University Hospital for Tom to be screened for the ARQ087 trial. Everything went well and we should know something tomorrow or Monday. If he is approved, then we’re moving forward with it for sure.
There is always a chance that there will be an initial response to the drug and then the cancer will find another pathway or gene to grow tumors. That was hard to hear and not something I had considered before. But if it prolongs his life and helps restage this disease, that would be wonderful. We were told that the trial itself, if he gets in, opens him up to other immunotherapy choices whereas that was never discussed with his primary oncologist (because chemo is the firstline, standard treatment and it is a repeat business – that part makes me so angry that healthcare hasn’t advanced more).
Emory Cancer Institute was PACKED yesterday. I looked around and wondered how many people were there for regular treatments vs. how many were there for trial appointments and trial screening. They do a ton of trials and I am so thankful for that + the participants.
A nurse yesterday said it was a miracle we got in when we did for Tom’s new CT scans because typically there is a 6 week wait time. If Tom gets into this trial, we will be so happy to help pave the way to new standard treatment options. I still can’t believe how much research, work and time an individual has to put in to find and then get accepted into trials.
I’m going to do some more reading on this board under the clinical trials section as I’m very anxious to see how people have responded within their individual situations.
Thank you, again, everyone. I appreciate any and all responses!January 18, 2016 at 5:30 pm #91237
Received an answer to my inquiry: failure to respond to prior treatment (including gem/cis) as well as patients ineligible for treatment or, patients not tolerating treatment are eligible for enrollment.
We may witness a major shift in regards to eligibility requirements for biological agents and I hope it carries over to other agents as well. I agree with Melinda, Stage IV disease patients should have the right to receive potentially promising treatments while still healthy and not when disease progression lowers their ECOG performance status. Their window for therapy is very short.
MarionJanuary 18, 2016 at 3:30 am #91236middlesister1Moderator
Think I just posted this on another thread and was worried about being diplomatic. With Dad’s new diagnosis ,they said that immuno therapies don’t work on many, so they go chemo route first. However when they do work- and with only minor side effects- shouldn’t that be an option especially if genomic test says it has a good chance? To put patients through chemo which extends life by 3 months and wears down health before admitting to trial seems wrong. I’m glad they are considering the rare cancer like CC on deciding what needs to be done first.
If I had won the power ball , I would have tried to address this.January 18, 2016 at 2:29 am #91235mbachiniModerator
OK, this is just my opinion only, but I say go for the trial! One of my biggest gripes is that we have to fail a chemo regimen before we can enter a trial. I feel that if we are wanting to try a trial that we would be stronger going into it if we had not already beaten down our bodies with a chemo regimen.
Now, an exception for me would be to do a chemo regimen in order to shrink tumor to have it surgically removed. If that is a possibility and there are no mets, then I would do it in hopes to gain surgery.
I was diagnosed at age 41, that was 6 years ago. I had liver resection with recurrence 3 months later to my lungs. I was then labeled stage IV terminal. I wanted to immediately start a trial, but couldn’t for insurance reasons at that time. I then did Gem/Cis for 6 months with horrible side effects, did Gem alone with growth of tumors, did Taxotere with horrible side effects. Four years ago, I entered into a clinical trial at NIH. I have had great success, but wish I could have skipped the first 2 years of chemo.
This is my opinion only, but I believe the treatments to come are going to be the game changers in this disease, and we wont’t have them until trials are available and patients are participating. I feel strongly about new options for all of us, and have high HOPE for what is to come.
Best wishes for your decisions, and know that whatever route you two go, we are all here to support and cheer you on! Prayers and hugs to you!
MelindaJanuary 17, 2016 at 7:48 pm #91234
jacdoll……..ArQule – sponsors of this trial – must have approved enrollment for CCA patients without prior treatment. This is not out of the ordinary and has become more common with trials for molecular alterations.
Targeted drugs interfere with its ability to promote cancer cell growth or survival are part of the newly developed Precision Medicine (treatments based on patient’s DNA alterations) and are studied in numerous clinical trials. In comparison to Melanoma or Small Cell Lung cancer, at this time, no targeted drugs have been approved for Cholangiocarcinomanone. It is for this reason that these agents are tested in clinical trials such as the one your husband may be eligible for enrollment.
This link, provided by the National Cancer Institute, allows for better understanding:
MarionJanuary 17, 2016 at 6:25 pm #91232
Yes, thank you Marion.
To clarify, the physicians overseeing the trial have approved Tom despite the initial inclusion criteria. Thy did not update the trial on clinical trials.gov for some reason. My guess is they really need participants and if we do this we are taking a risk.
Tom will be getting a final screen on Wednesday and we will know for sure soon if he has been accepted. No it’s not standard care but there’s a chance it could really work and we are willing to take that chance. If Tom is not accepted then it’s off to chemo we go.
Would love to hear from anyone in clinical trials for sure! I read a story on here yesterday about a few ladies in a similar trial at MD Anderson and it appears things are going very well for them which is very exciting!
I’m also posing the question about these types of gene inhibitor drugs. Are they the future treatment for this cancer? Anyone have any thoughts?
Thank you in advance!January 17, 2016 at 1:05 am #91233
jacdoll….thanks so much for sharing additional information with us. You are so right, this is the place to ask personal opinions and I wish others would help you out with this question. Unfortunately, we, the patients and caregivers (generally) are expected to make critical medical decisions for which we are unprepared, Input from others is so very important and much appreciated. This is what this board is all about, uncensored and open to all opinions. Occasionally thought and as it so happened in your case, I point out that absolute need for clarification with the physician is mandatory.
Jacdoll, I briefly perused the inclusion criteria. What stands out is the following:
“Failure to respond to standard therapy, or for whom standard therapy does not exist.”
I assume that prior failing with gemcitabine and cisplatin or any of the other platinums, the treatment of choice for unresectabe CCA, is not applicable for this trial.
I am thinking of you and sending strengths and hope your way.
Please keep us in the loop; we care.
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