Topic: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

http://130.14.81.50/ct2/show/NCT01093222

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Re: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Thanks so much for this info, Marion. Am having no luck getting through on either of the phone numbers...!
1. Basic question:
2. Can patients ever use these medications/drugs even if they are not participating in a trial? Meaning, what is the situation with off-label use of drugs? How can a patient get this?
In January, we did ask my mother's Sloan-Kettering oncologist about these two drugs (anti-angiogenetics, if I remember correctly??)- and numerous others, older chemos, new things, all found in our research- he seemed reluctant to recommend any for her due to "side effects"???
3. Last, any basic tips on how to get into a trial???
Thanks so much!!!!!!!

Re: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

The trial contact information has not been activated.  You might want to contact the Principal Investigator: Anthony B. El-Khoueiry, MD USC/Norris Comprehensive Cancer Center 
Ph: 323-865-3967; 800-865-0102
Email: elkhouei@usc.edu.
This is a multicenter clinical trial therefore, I assume that you might be able to find a physician close to your Mom's home.  That is of course, if your Mom's fits the criteria. Let me know if you need any help. 
Regarding the off-label drug use:  From what I understand, many cancer drugs are used off-label (if not most.)  You might pose this question to another physician actively working with CC patients. 
Good luck and please, keep us posted.
Best wishes coming your way,
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: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Very helpful, Marion. The fact that it is not yet open is GOOD- gives us time to learn, apply, etc.
In Stage 2, do half the patients get nothing??

I have a feeling there is something wrong with USC-Norris' phone lines- I got through to his office from the USC-CARE number...
I have spoken to a number of people I have reached there- they are saying that my mother would have to see Dr El-Khoueiry... will hear back soon I hope, as the multi-site designation leads me to believe that may not be true.
Need to talk to him or the N-P about this.

Meanwhile, we plan to show this trial to my mother's current docs- maybe that will convince them to allow her to give one or both a try, if she wants that.

VERY HELPFUL, Marion, I cannot repeat enough.
Is there a good place for me to trace a story like this about investigating a clinical trial on the CC.org site so others can learn from this??

Re: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Why don't you send him an e-mail.  Yes, you might have to see Dr. El-Khouery however, where are you located?  This is a multicenter study, SWOG approved therefore, numerous other centers will participate in this clinical trial.
Absolutely, you should discuss this with your Mom's physician. 
Everyone in this study will receive the same medications. 
You might want to familiarize yourself with the clinical trial process.  There are several links on our site or, you might want to go to the NCI site. 
First and foremost, the criteria will be the deciding factor for your Mom's addmittance to this trial.   Therefore, you will need to speak with a physician. You are doing just fine with your postings however, if you prefer you may just start another one please, feel free to do so.  We are learning as we are going.  Thank you for thinking of us.
Good luck,
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: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

This just came up.  You might have already seen it however, here is the link. (just in case.)
http://www.cancer.gov/cancertopics/fact … cal-center
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: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Hi Marion,
I have now talked to person at NCI hwo gave only very general help, and am still waiting to hear back from Dr El-Khoueiry's nurse-practitioner about the specifics of this trial.
Looking carefully over the eligibility requirements, one thing is looking very important- participants must not have had ADJUVANT or NEO-ADJUVANT chemo in last 6 months. I am not exactly sure what this means- my mother has been on chemo since Dec 24, 2009. It is her PRIMARY treatment.
Also, the many bone mets she has may make her cancer "UN-MEASURABLE."
And, obviously, her blood values could be off.
I am trying to pre-vet all this so we do not rile her up about all this for no reason. Her local oncologist is also a bit balky about things.
I think we may end up just trying to get access to these drugs off-label somehow... but it takes the right doctor to accomplish that. This is all so complicated.
[My mother refuses to travel around looking for help- it has to be a really good prospect to get her out the door and on the plane again... She  and my father live in Florida; I live in SF CA. She has already been to Sloan Kettering (in Nov and Dec) to get the initial diagnosis confirmed and the first treatment plan. She is on gem-cis-- will hear if it is working soon.
My father seems think that Dana-Farber has some good promise.
I have had a hard time trying to distinguish among the cancer centers' relative expertise on very advanced cases of CC. Ideally she needs help with the bone mets...]
Anyway, I always feel as if we are going around in circles!!!!!
Thanks to you for all your help and to all the others who post and share so much.
God bless you all.

Re: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Final Chapter to the Clinical Trial story:
I reached a "trial nurse" at USC-Norris, LA about the upcoming CC trial led by Dr El-Khouiery ( presenting at the May conference, btw).
My mother is NOT eligible because she has had prior systemic treatment (chemo) to her metastic CC.
It was good to be able to reach someone who could help me decipher the eligibility requirements listed on the clinical trial abstract.
I also asked about research on the small (less frequent) cancers: she said that docs do it partially because it can yield interesting info about the larger cancers.
As to use of off- label drugs and therapies, she said it is legal, but that insurance does not usually cover it.
She suggested that I try to get a referral to a doc with good knowledge of cc nearer my mother (who is in Fla) from Dr El-Khoueiry, via the USC-Norris referral department (we shall see if the system works!!).
While this may seem like bad news, the conversation was supportive, helpful and informative. I feel much more "plugged in" and hopeful that here may be a way for my mother to access some other treatments.

Next Story will be: getting a referral to a Creative, Compassionate and Careful doc with lots of experience with stage IV CC for a second opinion... If this story ever happens, it will be in a different section.

9 (edited by marions Fri, 04 Feb 2011 02:28:55)

Re: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

sharpeilover....I agree with you.  Knowledge is power.  It enables us to make decisions based on facts. 
BTW, Dr. El-Khoueiry has extensive knowedge of this cancer and has published numerous studies on Cholangiocarcinoma.  He would know whom to refer your Mom to.  I hope that you will receive an answer soon. 
You are very proactive something your Mom must truly appreciate.  I wish you luck with with all further searches.  Please, keep us informed as your information sharing is much appreciated. 
I live in the North Bay; not too far from you. 
Best wishes,
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: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Wondering if anyone is on this trial?
Thanks,
Thirdone

Re: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

My mom has just been diagnosed with CC in the last month and this Trial is being suggested.  It does not look like anyone has posted in a while and I wanted to see if anyone has participated or knows anything more about it other than what the doctors are telling us.  I will go to the intro tab later to introduce myself. Does not appear to be much in the way of a cure.  They told her 1 year with no treatment, is this typical?  She has no physical symptoms yet?

Re: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Sidig...hello and welcome to our site.  Hopefully, someone will come forward and answer your question regarding the above clinical trial.  Although, you have been given a general time line, on this site, we continuously have seen people far surpass the physician's prognosis.  Therefore, we stay optimistic and realistic.  Have you consulted with another specialist also? 
Please, tell us more.  The members on this site are always ready to lend a hand.
All my best wishes,
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: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Marions, thank you for the Welcome. She has has all her tests done with MD Anderson (Orlando) up till now.  We have an appt. next week with Mayo (Jax) for a 2nd.  We are supposed to find out if she qualifies for the trial tomorrow and anxious to start any kind of treatment.  She was supposed to start chemo but then the trial talk started.  Like many others the lack of treatment protocols is frustrating.  we were told Chemo won't "treat" her just fight off anywhere else the cancer  may be. I missed her last appt. and frustrated she did not ask what their actual recommended "treatment" will be outside of systemic focused Chemo. I'll intro on the introductions page and look forward to talking with others.  I am trying to get my mom on here to share and learn from those bravely battling, but we will see. Blessings!

Re: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Hi Sidig,

My Dad is on this trial.  Unfortunately, last week he had a bleeding ulcer, was hospitalized for 5 days and has stopped the medication.   He is having a CT scan tomorrow and has an appointment next week with his oncologist.  At the appointment, he'll see if he resumes the medication...maybe the dose will change?   I like the idea of options!  In December,while on this trial, my Dad had a scan and the doctors said the tumor shrank, a tad. 

Please let your Mom know that my Dad had cc 15 years ago. 

Thirdone

Re: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Thirdone, thank you for that very good to know.  My mom starts the trial today in Orlando, fingers crossed and prayers for a positive outcome. Trying to keep her hopes up but difficult.

Re: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Thirdone,
I noticed you put your Dad had CC 15 years ago.  How was he treated then that he was able to keep it away for so long?

17 (edited by thirdone Tue, 08 Feb 2011 22:30:48)

Re: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Hi Sidig,
My Dad met with the oncologist today.  They are starting him back on the trial.   The ulcer might have been caused from ibuprofen.  Prayers for your Mom and please keep us updated. 
Thanks, Thirdone

Re: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Thirdone, Great to hear your dad has started up again, "hopefully" the Ibuprofen was the culprit!  My mom's spirits are up this week after starting the medication on Monday AND what I think is good news (and more importantly what she sees as good news) is...last week they had her re-take all the tests she had to diagnose the CC (PET Scan, bloodwork, etc. ) to establish the baseline for the Trial and she was told they did not see any percievable growth in the existing tumors!!  Her attitude for now has really changed for the positive, so we are happy for this and starting treatment. Still good but told she probably would not start experiencing much in the way of side effects until the 2nd round of treatment. 

How long has you dad been in the study? How long until he started experiencing any side effects?  Do you know if they would allow him to take Vitamin D3 or would this be off limits while in the study.  Mom is going all out to eat healthier (although I am encouraging her to eat MORE). I cant' say I agree with the limited food intake she is following but whatever make her feel better is good for me. She has many friends who care a great deal, sharing pos. experiences of other survivors and encouraging her to do supplements, teas, etc. and this worries me because I want her to trust the doctors until a time we need to try other alternatives.  Any suggestions on how to work with her on this type of intervention?

Re: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Hi Sidig,

My Dad started the trial in October.  He told me that he is on his 5th cycle.  Two weeks after he began the trial, he had a pinpoint rash.  (the rash never bothered him...located on his back and belly)  Shortly after the rash began, the skin started to peel on his fingers & toes.  Also, his heels were tender and at times, he felt cold.   He has started and stopped the trial twice.  Once, to have a stent put in and than two weeks ago, he had the bleeding ulcer.  He does drink tea.  He eats a regular diet, no alcohol. 

As for the additional information from friends, the internet, etc...maybe your Mom could write down the ideas, and share them her doctor.

Glad to hear your Mom's spirits are up! 

-Thirdone

Re: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Great news! After the first  2 months of treatment on this trial we learned today there has been a 3% reduction. Mom is a "reserved" happy, she wanted it gone. Obviously that was not an option after 2 mos, but she is doing well and still only minor reactions (mainly just a rash on her hands). She is lucky enough to be continuing the trial for another 2 mos.  Slow but sure is the course. Any reduction or no growth is a blessing!

Re: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Sidig....We have learned to appreciate the word "stable" and are thrilled to hear "reduction."  It appears that your Mom is only experiencing minor side effects.  May the good news continue.
All my best wishes,
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: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Hi Sidig,

Thanks for sharing your mums great news with us, we love hearing news like this! Glad to hear that your mum is feeling well and has only minor reactions, and hopefully the next 2 months of the trial will go equally well and be successful also. And yes, any reduction or no growth is indeed a blessing.

My best wishes to you and your mum,

Gavin

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: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

I have a question for anyone in this trial....my mom has been in this for about 8 months and happy to say she is holding her own, not much in the way of side effects although there have been some, (I would consider minor in regard to what chemo would bring).  Her growth(s) have not been increasing and have possibly gotten a little smaller.  Waiting on next scan as one did show some increase however with others "possibly" smaller they think it the scan may have been off a little bit and did not measure the exact "slice".  Her Ca 9-19 number have been up or down....back in Dec.2010 when diagnosed it was around 48.  Up and down since and up to 150 now. Most times up or down only 5 or 6 points.  She is a little discouraged right now...probably more time to think about things after the 6 or 7 trips she has taken the last 9 mos however she asked me to write.  I think this is minimal movement however the 100 point up since starting is freaking her out a little...is anyone experiencing Ca9-19 up and should this be any type of alarm.

Thank you in advance

Re: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Sidig....I have been told that variations of the CA 19-9 are to be expected.  Five or six points don't mean much and easily could be dismissed.  A consistent rising of these markers however, may (and I emphasize "may") indicate progressive disease only when substantiated by other test results.  It is the trend (upward or downward) that the physician will look for.   I so much understand your Mom

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: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients Wi

Marion, thank you for the clarification, you help is soo apprecatiate.  It looks like they verified two of the tumors shrunk but the 3rd had increased a little and with the new blood test the increase in CA-19-9 is apparently to much....they are taking her out of the study and recommending the start of Chemo, mom is verifying what drugs but i think the standards I have seen hear are what they are moving forward with.

I have a question though....her doctors are saying SHE is "free" to find another study to try and how far she is willing to travel or come back in two weeks to start the Chemo.  They said they do not have the time or resources to assist in finding anything else other than the Chemo....is this normal....no more use to the study so on to the standard route....is this typical?