Has anyone heard of this study or know anyting significant about the agent? Or even the idea? I am elegible and am going to ask my medical onc. about it in May when I see him (or earlier, depending upon my patience). Seems like a good approach to continue to defeat this and there doesn't seem to be a downside, unless I am missing something.

The Study title is: Adjuvant Erlotinib After Completing Chemoradiotherapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck.

It is defined at: http://www.clinicaltrials.gov/ct/show/NCT00079053?order=93

Do you still have residual disease after all of your treatments? If not, this trial is not for you. Be aware that this is a stage one trial. That means it is small in scope and they at this stage do not even know what dosage might be appropriate. Stage one trials are gathering very preliminary data. If you do not continue with disease, this is not a trial for you. I recall your original post stating something like your oncologist said a better outcome could not have been written for you. Given that I am lead to believe that you are disease free at this point. That makes you not a candidate for this trial. While I am a big proponent of clinical trials, only those in dire straights end up in stage one trials...

Tim, I agree with Brian that as you have finished your treatment already, you are not eligible for this phase 1 clinical trial. Before my treatment, I was given an option by my hospital to join a clinical trial of Phase 2/3 (can't remember exactly the phase no. but definitely not phase 1)to test the effectiveness of concurrent chemo and radiation treatment on stage 3/4 head and neck cancer. A lot of research was carried out and I was more closely monitored than others. The trial still goes on and I was told by my oncologist that I might have a chance to share my experience in an international conference to be held next year.

Karen

Your recollection is perfect, Brian. My result, so far, is as good as it gets. I also understand that the trial is phase 1 and is mostly an MTD study. It also seems as though this is a trial that is looking for a prophylaxis for recurrence, and it is specifically designed for people who have completed treatment and do not show evidence of disease. The inclusion criteria are listed as:

"Criteria

DISEASE CHARACTERISTICS:

-- Histologically confirmed squamous cell carcinoma of the head and neck Stage III, IVA, or IVB

-- Must have completed cisplatin- or carboplatin-based chemoradiotherapy within the past 4-12 weeks

-- Prior radiotherapy must have been given with a radical intent with receipt of at least 90% of planned dose

-- No evidence of disease or presence of inoperable minimal residual disease, defined by 1 of the following:

- Complete response at primary tumor site and nodes (with or without nodal surgery after chemoradiotherapy)

- Negative lymph node status (by physical or radiological exam) AND persistent tumefaction less than 25% of original tumor size or residual mass due to scarring

- Tumor tissue samples available for EGFRvIII mutation analysis

- No known brain metastasis"

This almost seems to have been written for me. Completion of chemoradio therapy treatment with complete response and no evidence of continued disease.

Since recurrence of SCC is an ongoing fear of all, this just seemed to me to be a great trial for me. It is designed for prevention of recurrence, not for cure. The drug is generally safe and has been approved for use in NSCLC as a seocnd or third line chemo treatment.

The downside (and this is just my own cynicism) that I see is that if a recurrence does occur while in the study, will the use of the drug prevent the use of known effective treatments.

It was all of this (plus my own desire to DO something to help my self . . . and others) that led me to look into post-treatment treatments.

Perhaps I am misguided.

Thanks for the input.

Tim

I was wrong in reading the trial requirements, and as you have indicated no evidence of disease is the criteria. While clinical trials are an important part of developing our knowledge base, it takes a special kind of person to want to jump into a phase one trial. There are REALLY a lot of unknowns. I don't know that I would be able to make that choice myself. I know that people, me included, want to feel proactive in their treatments and in staying healthy and disease free after them. And in other threads, there have been discussions of chemo preventative drugs and foodstuffs that might benefit us. But I kinda get to a place where I am not willing to get into things where the downside is not well defined. It would seem that any altruism that I possess, does indeed have limits...

That's my concern. What's the downside? Will it prevent the use of a known treatment if a recurrence does occur? Etc.

I have had a significant amount of experience with and exposure to clinical trials for a variety of drug substances over the past few years. One thing I have discovered is that there is almost always an unstated or suspected downside. The other thing that I have learned is that the potential patient population is where that information resides. With such a vested interest, I think this population just tends to think a bit more aggressively that the doctors.

I agree with your assessment of altruism . . . It would be one thing if I were 80.

For the time being, I will stick with a well-balanced, low fat, fruit/vegetable heavy diet. I will, tough, talk to my medical onc. and see if he has a comment. I'll let you know

Tim, I have been following this thread and thought about posting twice befor this. I didn't because I didn't want the responsibility for urging you to do this or not to dothis. In other words I am in the same boat as you (well except that I don't have the real worry).

On the one hand this could help you and also help fellow cancer patients. On the other hand you might find out this stuff is really bad.

The reality of phase 1 testing is that someone has to do it........

So while this note probably won't sway you one way or the other, I just want you to know that someone else is contemplating what decision you face. (part of that positive vibes thing)

In some quick searching I found positive information in that this same drug has been through clinical phase III testing for non small cell lung tumors. Those studies found an improvement and fairly low side effects.

I'd like to hear what your Onc. says.

Thanks for the support, Mark.

Fortunately, it isn't so much a choice that I face right now. The fact of the matter is, I and my doctors did really well in getting rid of the appearance of this disease (who knows what the scan will show). Now I just want to do what I can to make sure that it doesn't return. So I am looking at a variety of things and sources and strategies. Good diet, exercise and attitude seem to be the front-runners ;-)

Whether this is really "bad" stuff, I think that is unlikely. It is an MTD study (Maximum Tolerable Dose), but the underlying drug, Erlotinib, has been approved as a cancer fighting drug on the second or third line.

I have begun to wonder why this substance was chosen, given that it is not considered a first-line fighter.

Tim, In my way of understanding I'd guess that these new options won't replace first line fighters like surgery and radiation, because surgery and radiation are well known with predictable results. To replace them with something would require a significant leap of faith. Imagine if you were asked to be in a phase 1 trial of such a replacement, that would be a pretty easy decision in my book. (at least until there were many years of experience)

I heard from my oncologist. He was pretty neutral about the idea. While in theory it isn't a bad idea, it would require moving to Canada. Too much trouble for no ascertainable benefit. He didn't sound as if there were any major medical or therapeutic downside. It is worth keeping an eye on, though.

Hi All,
I too have been following this thread with great interest. I could have sworn that I read this is a small patient group - 6-20 patients and in Canada. What are the possibilities of entering a clinical trial in a foreign country? Also, isn't phase 1 typically about determining levels of toxicity more than therapeutic benefit which is more of a phase 2 thing. More Brian can expound a little on this.

Hi, Gary --

You are correct both on the size/location and the focus of the study.

As for being able to participate in a "foreign" study, there is no easy answer. It really is a study by study determination. Suffice it to say that there are many, many cross-border studies.

This one, given its size, would probably require either moving to Canada or, perhaps, getting your doctor registered as a study investigator. His/her affiliated hospital may balk at that for a single patient.

As for the focus of the study, yes it is an MTD study and has been designed to give statistical picture of the maximum tolerable dose. It is not designed, from a statistical perspective, to provide insight into therapeutic value.

That being said, to say that it deals in toxicity only is somewhat misleading. If it were designed ONLY to determine toxicity, the eligbility criteria would be healthy individuals. Here they are looking for participants from the patient population that they eventually hope will be therapeutically served. Thus, they must have shown some evidence of efficacy (even if it were only anecdotal) otherwise the ethics committee overseeing the study design would not have approved the design. This of course may not hold true in, say, Belarus . . . .

I am not an MD or even a researcher. I have had a good deal of exposure over the past couple of years to a wide variety of drug studies and study designs including transnational studies, however.