Just wondering if either of you have made your appointments yet to screen for these studies? Mine is for third week of March.

Amy...I have made contact with the research nurse. I am actually outside the time restrictions (one year post-treatment) so she felt that they probably could not admit me to the study, but she was going to look into it. I have learned a bit more from Russell, and I am beginning to feel a little leary about the repeated bronchial biopsies. The nurse has called me back and left a message for me to call her. I will do that tomorrow, but I doubt that I will have to worry about being accepted. I'll let you know.

I went back and re-read this thread with interest today. I have also been asked to participate in a clinical trial at MDA. They spoke to me about it on my last F/U visit 2 weeks ago. It's the "EPOC" trial - Erlotinib Prevention of Oral Cancer. Erlotinib (Tarceva) is a drug that blocks the activity of an enzyme found on the surface of many tumor cells that may control tumor growth and survival. It is already approved for tx of non-small cell lung ca.

Here's the interesting thing - the main screening test involves testing the tumor tissue they removed during my surgery for certain genetic markers that indicate a higher risk of recurrence. Apparently this screening is fairly new. Since my Dr at MDA has always told me I have a very low risk of recurrence (he says he thinks 5%) I figured I would not qualify, but at least would know. Well here's the bad news - they called me yesterday and told me that I do qualify - which means I have those genetic markers present, indicating a 65% chance of recurrence in the next 3 years.

Is anyone else in this trial? I am going to go ahead with the next steps, which involve additional exam and screening. I figure it can't hurt to have the extra surveillance even if I end up with the placebo. It's kind of a downer, though, knowing that I have those genetic markers...

Keep us posted please, I think this is very interesting. I've necer heard of screening for genetic markers as far as recurrence was concerned.

Tim

Ginny,

I am in Houston now - I don't qualify for the Green Tea Extract trial that my doctor referred me for - but they are screening me for the EPOC trial. To be honest though, I don't know that I'll do it even if I qualify.

The way they explained it to me - was that it wasn't necessarily a hereditary genetic marker - but more of a mutation of sorts where two genes get deleted and cause you to be high risk for recurrence. That is my understanding - however, I could be off base on that.

I just agreed to screening on Monday - and they have to obtain additional slides from my last biopsy as they didn't send enough to do the testing. Like you, I figure I'll wait and see what the results are and at least I'll have that info. However, the side effects of Tarceva don't sound too pleasant. From what I read - most everyone gets the rash and most people get the diarrhea and a lot have nausea....plus there is a multitude of additional side effects that are much less common. HOwever, you'll probably know quite quickly if you are on placebo by a lack of side effects.

For me, expense comes into the picture as well. Since this is a National Cancer Institute sponsored trial - there is no reimbursement to participate and since I'd be traveling from Cincinnati, that would be a pretty big expense, as I'd have to come back for another screening visit, and then at months 1, 2, 3, 6, 9, 12 and every 6 months after for 2 years. I don't know that I want to go to that expense for a trial. Now, if it were a proven treatment - that would be a different issue all together.

I am however, slightly annoyed that they insisted that I stay in HOuston for 5 to 7 business days for the screening and it really only required 3 days (which would have been one day if one of the doctors had not taken a vacation day at the last minute). They tried to reschedule me for the other doctor on next Monday, but I wasn't staying for that long with nothing to do and no testing that was being done and so they worked me in today (Wednesday).

Good luck and let me know if you enter the trial. I'll be a couple of weeks behind you if I decide to do it.

Amy - I sent you an email to your own email address. I was very interested to hear that they were also talking to you about this trial - I knew you were considering the Green Tea trial and I actually asked the reseach nurse about that one...she said it was about full.

I will keep everyone posted as to what I learn about this. I am tentatively going back in 2 weeks and will have an opportunity then to talk with the principal investigator, and plan to ask a lot of questions about this new test. They will do additonal screening then, and if I pass, I will start the trial. I am lucky in that I am already being followed at MDA so it's only a few extra trips, and I travel for business so have lots of frequent flyer miles.

The side effects do worry me but so does the knowledge that my recurrence rate just jumped to 65% - so in weighing all things I believe the extra surveillance I will get as part of this trial can only be a good thing... and even if I am on the placebo, I will hopefully help further the research into ways to prevent recurrences...I read about everyone who is going through those recurrences and my heart just goes out to them - and everyone here who is facing this disease, whether patient or caregiver...

Here is the link to the trial synopsis on the FDA website for those who are interested. They do not have it posted on the MD Anderson website currently.

http://www.clinicaltrials.gov/ct/show/NCT00402779?order=2

Hmm I have re-read Amy's and Ginny's entries about this trial. I have also sent an email to the researchers, but I doubt that I will qualify, since it has been over a year since my diagnosis.

NOTE: If anyone thinks that they might be interested in a clinical trial, most of the ones I have seen have required enrolling within that one-year window.

I am not sure that I want to know if I have the increased recurrence marker......will have to think about that.

And the drug sounds more than a little un-pleasant, unless they have some reasonable expectation that it will be effective against recurrence.

I doubt that I will have a decision to make anyway. I'll keep you posted.

How can I contact the research nurse about the green tea study? I know that you said that it is nearly full, but you never know. Maybe they need one more Southern girl in their study.

Colleen - here's a link to the info regarding the green tea extract trial on MDA's website. If you look, there is another link on this page where you can contact someone about your interest. http://utm-ext01a.mdacc.tmc.edu/dept/prot/clinicaltrialswp.nsf/Index/ID01-155