Nervous about trial exclusions
 

Hi all,

After 3 weeks of low dose Adriamyacin, Caryn's markers have shot up and she is off to Sloan on Tuesday to discuss a new trial. While I do believe there are good trials out there like herceptin dmm1 I am very concerned that Caryn will be excluded from most due to previous treatment. Seems like the only available trials at Sloan will be phase 1. With the success rate of phase 1 trials being very low I want better odds for her! I know how important these trials are and I feel badly but I just don't want to risk losing the center of my kids universe and the best thing that's ever happened to me. I understand it but hate that the numbers are more important than the valuable lives that the drugs may save.

Thanks for listening!

Eric

Eric, I know you guys are going through a tremendously difficult time. You're dealing with something nobody should have to deal with, as a good friend said to me. Try to hang in there until Tuesday. I'll be praying for you and Caryn that new alternatives and trials will be presented to you then. You guys are in my thoughts and prayers.

Thanks Bill.

I too will remember you in my prayers.

Eric,

I just wanted to add my prayers. Please know that I will be thinking of you and your family on Tuesday.

Eric, I share your frustration at the exclusion criteria for Phase III trials. I don't know the answer either, but I'll be thinking of you both on Tuesday...keep us posted.

<3 Lolly

.....always the waiting time ....!!!but, hang in there ....I will do the same thing with my test's tomorrow .....Caryn and you will be in my prayers ...

Hi Eric,

Thank you for sharing your feelings with us here. The "fear" you feel is "heard" here and my heart goes out to you. I want to say that I am sorry you two are having to go through this. I truly am. My prayer for good news for you on Tuesday are being said as I type this. I also ask our Lord to give you His strength and Peace as you wait.

Love to you..................from my heart....

Mary Jo

Eric,

I will keep you and Caryn in my prayers for Tuesday and every day. I know how difficult it is for you both.

Thank you all. I appreciate your prayers and thoughts. Lily, my prayers are with you for your test results as well. Please let us know how they come out.

Love to all,
Eric

eric.. the phase one trial of trastuzumab-dm1 is the same as the phase 2 trial. except phase 1 is given each week vs.. every 3 weeks..

also the phase 1 has fewer limitations than the phase 2.. p2 excludes patients who have maxed out on adriamycin...although i hear they are moving to amend that limitation as we speak.. also the phase2 limits patients to a max of 3 prior regimens of chemotherapy.. which also may soon be amended..

do not be afraid of the class of trial ....phase 1 vs phase 2 or 3 etc....

genentech is already making plans for approval of this product.. i dont have the link available at the moment but genentech already has in place the ability to mass produce and distribute this product upon approval.. they also have the ability to make pivotal trial material TODAY...
the response rate for the tras-dm1 trial has being nothing short of phenomenal for the ladies on this trial ... reported at SABC in dec 2007.. 12 of 15 patients dosed every 3 week achieved stable or partial response.. which is a far greater response than herceptin alone.. genentech likely already has enrolled /treated close to 50 patients in the phase 2 portion of this trial...

the initial phase 1 trial is close to full enrollment at the only 4 sites available..
talk to caryns doctors... the phase 1 or p2.. if she can get into it.. has worked very well for the 5 ladies on this forum who are currently being treated.

good luck and god bless

run to live..

That's great info Runtolive. I will discuss tomorrow and keep in mind at other locations based on Sloans recommendation. I hope to have a direction and update for everyone tomorrow. I do feel a bot better thanks to each of you. The info, support and love...it all helps. Thank you!!

eric.. dr shanu modi.. is one of the clinical trial leaders for genentech

http://www.mskcc.org/mskcc/html/2270.cfm?IRBNO=06-049

run to live

Dear Eric,

You and Caryn and in my thoughts and prayers each and everyday. Please le us know how you make out.

how has caryn been doing in the trial. fewer side effects i hope..

run

Hi Run,

Caryn had missed treatment 3 of the last 4 weeks due to side effects. Fortunately, Genentech has agreed to lower the dosage for her rather than exclude her from the treatment. We're thrilled since the treatment was doing so well against the cancer.

Thanks for asking!

Eric

That is good news, Eric, regarding the lowering of the dosage. You and Caryn stay strong. For what it's worth, you're in my thoughts and prayers, Bill

Good News !!!

Eric,

This is wonderful news about Caryn's response to the trial drug.

This trial was recommended to me on Monday by an oncologist at Sloan in lieu of surgery to remove a solitary lung met. But I'm not sure whether it's still open and plan to call the study doctor tomorrow. If it's open I'm thinking about participating in it.

Best, Joan

Eric, that's great news - hopefully giving Caryn enough of a break to recover more from the side effects while still being able to keep T DM1 in her arsenal.

I know Caryn is in a different trial than I am, but my trial coordinator (who is unnervingly overwhelmed by the protocols!) showed me the protocol book and while browsing I found the clause about allowing for the possibility of continued treatment based on "continued clinical benefit" even with side effects - the doctor in conjunction with the Genentech medical monitor do have some wiggle room!