I have been asking a lot of questions lately and have received so many thoughtful and helpful replies. So I should start with a big thank you to everyone before I ask yet another question. Thank you!!

I am starting radiation in a few weeks and my RO offered to enroll me in a clinical trial for Erbitux. It is randomized and only half the patients will receive the drug along with the regularly prescribed course of radiation. The trial includes 5 years of extra followup after treatment plus an annual checkup for the rest of my life. I've been reading about Erbitux and the side effects seem manageable in most cases. I have read some posts here from people who had quite a rough time of it, though. I like the idea of the extra follow up, the possibility that it will improve my chances for disease free survival and it seems like a good thing to help with the research. I'm not too crazy about the idea of additional side effects on top of the radiation and it is kind of a big time commitment plus the drug may turn out to not be helpful in cases like mine. Patients receive 11 weekly doses of Erbitux starting the week prior to radiation and there are additional appointments involved as well. If I am in the group that doesn't get the drug, I will still have the additional followup appointments, etc.

I would be very interested to hear about anyone's experiences with Erbitux specifically and clinical trials in general, both good and bad. I have read many posts on the forum on this topic and have done quite a bit of googling as well, but would also really appreciate any additional suggested reading that might be helpful.

I woud help you if I could but I was given cisplatin. Good luck - it's a tough decision to make-

Hi Tracy,
I'm not sure if you have gotten to the point in screening for the study when you would discuss being a nursing mother. But, Erbitux may be excreted in breast milk (as well as other bodily fluids.) I know that it is of utmost importance to maximize your treatment options. But, if it is a blind study, you would be discontinuing nursing possibly for the sake of receiving a placebo. Just thought you would want to be aware.

Erbitux can be a phenomenal addition to radiotherapy. If you have read anything I have posted about J's misadventures with Erbitux, please don't let it scare you away from it.

I hope you get a variety of responses so that it helps you make the informed decision you desire.

Sandy
xoxox

I'm not sure about this study but Johns Hopkins is doing a study on Erbitux alone for people with severe dysplasia and they do not give a placebo to the control group. I considered participating in this study through their partnership with the Medical University of South Carolina but opted for surgery- Not because of concerns about the efficacy of Erbitux but because I was concerned about my dysplasia and it turned out I had more cancer.

I'm very interested in the results of this test as early results look promising.

Best of luck!

Sandy, they did tell me that I would have to stop nursing. They are not giving a placebo to the control group, so it would only be if I am actually given the medicine. That is definitely one of the factors I'm considering. I think it's better for the baby to have a healthy mother than to continue nursing, but they said there is no proof that Erbitux would be helpful in a case like mine. Hence the clinical trial, I guess. I am leaning toward doing the trial. I read that clinical trial participants do better overall, even when not receiving the trial medicine. I guess because of the extra attention from doctors.

I figured you probably already knew about the nursing issue.

There isn't adequate screening yet to find out if specific patients will benefit from it or if they won't. That's what bothered J and I about having him go on Erbitux for 8 weeks. But, we thought it was better to go at it with everything the doctors were able to give him. Adding Erbitux to radiation wouldn't do anything about distant mets (they'd be undetectable at the early stage) but it could help avoid a local recurrence. So, avoiding it in the same area was what appealed to J, given his situation.

I pumped and dumped for a couple of weeks when my oldest was a newborn so that I could take an antibiotic for strep. I nearly lost my milk but it came back. My biggest problem was getting him on formula. It was a little rocky at first but it all worked out fine.

I feel like your post and signature would be a mirror image of my own. I have been dealing with leukoplakia and recurring dysplasia for about 5 years now and was recently diagnosed with cancer, t1n1. I also applied for the study your were asking about and was told I got randomized to receive cetuximab. I will start on 7/18 and will take my first radiation treatment 7/25. Did you decide to enroll in the trial, and were you randomized for it?

I did enroll in the trial and received my first infusion yesterday. Best of luck to you!

Hi, msmac
Did your Dr. started you on the antibiotic minocycline yet? If you do get the rash, it has some success in helping to keep it under control. As far as topicals go, Aquaphor worked well for my husband - but if I missed even a day of applying it got worse again fast. Apply whatever topicals you end up using to the radiation field after the IMRT.

There is a correlation between a prominent rash and doing well - but still much disputation over what the rash actually means. Best of luck to you in your treatments!

Thank you, Maria. I have had the rash for a few days now. I'm not taking any antibiotics yet but I have been putting on the aquaphor each day after radiation. Thanks again for the tips.

You've got your rash first cycle - that's really good. Ask your MO about the minocycline when you get the chance.

Interesting trivia note: Apparently Erbitux is the drug developed that caused such a stir on the stock market and landed Martha Stewart in jail for insider trading. It was first discovered as an alternative to chemo to treat late stage colon cancer which was a big deal. So because of the legal proceedings, it wasn't marketed until just recently, but in the meantime, it was discovered that the drug was also effective for head and neck cancers. (That was per my primary oncologist, but I'm sure anyone interested could find the story online in more detail.)

I will have 7 Erbitux treatments, once per week, along with radiation all five days. I've had the first one, the intro where they inject other antibodies first to see if you might have an allergic reaction, and had no problems at all. I'm all prepared for the rash, but frankly, that's the least of my worries.

Maggie

Yeah, we've had postings about that aspect of Erbitux here before. Too bad Martha didn't hang onto her stock, instead of taking bad under the table advice over one piece of the clinical trial data� she would have made lots of money instead of wearing those funny clothes for awhile.