Hi Colleen,

I just wrote a really long post and it didn't work - so now, I have to re-type.

I am also screening for a trial at Anderson in March. They have you come in for 5 to 7 days and do the whole workup as a new patient and see what you qualify for. At least that is how mine is being handled - even though my doctor has recommended one trial in particular. I think they do that so that if you don't qualify for one - you might qualify for another and they wouldn't have to waste time with more tests etc... I've not screening for the trial you mentioned though as I have never been a smoker.

They also will want your insurance info - to make sure they are an In-Network provider or if you need to apply to have them added to your network. In addition, you will have to have all of your records, slides and other things forwarded to them before the appointment. (Again, this is how my case is being handled)

I have a few things that I'd like to add regarding your post from above. I work in clinical trials and so this is where the info that I am writing is coming from.

In your post - you mentioned that you cannot take celebrex due to your allergy to sulfa drugs. Usually this will prohibit you from entering the trial if celebrex is the study medication. The reasoning is that most trials are single blinded (meaning you the patient, do not know if you are taking study medication or placebo) or double blinded (both you nor the doctor know which arm you belong to). Only in an open label trial, will you know exactly what you are taking (and there is no placebo in open label trials). From the sound of this - it sounds to me like you might have a placebo arm (the one you would qualify for). In cases like this, you generally would not be permitted to enter this trial, b/c it would be dangerous for you to receive the study medication (celebrex) and since you are not supposed to know what you are taking - or which arm you are in, this would not work and would be quite dangerous and risky to enter into. Also, if this is the case, the FDA would not allow it.

However, I wouldn't let that discourage you from screening at Anderson as they have other trials that you might qualify for that would also give you the added surveillance you are seeking. The trial I am looking into involves a green tea extract and is a prevention trial as well.

Also, you might find the www.fda.gov website helpful. On the right hand side of the page, you'll find a link for consumers link for clinical trials. This will give you some great information regarding how trials work and are set up. Also, how your safety is maintained.

The FDA governs all Phase I through III human clinical trials. They approve the protocols and make sure that subjects (patients) are not going to be harmed unnecessarily during a trial (although that is always a risk of an unproven drug or therapy).

In general, You'll definitely want to know what Phase of trial you are entering and make sure you ask lots of questions before entering. Also, remember that if you ever get uncomfortable or are having reactions to the drugs / or are just not comfortable with the treatments, that it is your call, and you can discontinue the trial at any time.

Here are some basics on the phases:

Phase I: These are usually the first trials in humans. These trials are usually done only in young, healthy men (wouldn't want to risk a birth defect in a woman with an unproven drug), and are testing the safety and tolerability of the drug in the human body. This is the phase where they usually also determine the maximum tolerated dose the body can handle. In some trials, they will escalate the dose until the patient shows signs of toxicity. For Cancer and AIDS trials, however, they do not generally use healthy men as it would be unethical to subject healthy people to some of these drugs, so generally (but not always) they will be people who have tried everything else and nothing is working. These people are out of options in many cases and this might be a last hope.

Phase II trials: These are where the efficacy trials start. Does the drug work for the condition it is intended? Are there obvious side effects?

Phase III trials: Here they are fine tuning the drug, testing in a larger number of people (there might be a side effect that only 1 in 1,000 people or less experience and you might not see it in a small scale trial) and FDA applications for drug approval usually follow several Phase III trials for each drug (If studies show that it was effective and safe).

Phase IV trials: These are after market trials. The drug is already FDA approved, but they might be researching a new indication (for instance, I recently saw a trial for the reduction of leukoplakia lesions and the drug was Actos (a diabetic drug), I think this was a phase IV - but I can't remember for certain). Also, sometimes, they are just gathering more information on different populations. Maybe the original trials didn't have enough of a certain race or age group as drug can act differently in different ages and races.

I hope this information helps. My history is like yours, surgery only.....and I know that the added surveillance is welcome, so I'd definitely encourage you to explore this option.

Also, check into your insurance. I have United HealthCare and I just found out that I have a wonderful rider policy which gives me access to all of the CCCs in the nation at the In Network Rates and Copays and also includes a travel allowance that will allow me to go to Houston and they will reimburse some of the costs. In addition - this particular rider also covers clinical cancer trials - if there are costs associated with them. Not all insurances have this option as my plan during my initial diagnosis did not have anything close to this benefit.

If you have any questions related to trials - feel free to ask and I'll answer if I know. Also, let me know if you decide to screen - we might be there at the same time and could meet for dinner or lunch or something.

Amy M.