Hi my name is Barry.

I was diagnosed with stage 4 SCC two weeks ago. Since then I have had two consults [at Johns Hopkins and Sloan Kettering] and have done a lot of reading. Both consults recommended chemoradiation treatment. I will be meeting with both a medical and radiation oncologists at Johns Hopkins this coming tuesday.

While doing my research, I read a 6/7/04 news release that indicated a new drug [Erbitux] "in conjunction with radiation nearly doubles the survival time compared with patients treated just with radiation with relatively minor side effects". Sounds almost too good to be true!
The news release indicated that this drug was in a phase 3 trial and FDA was expected to review these trials in late 2004 and if approved the drug would be available for patients in spring/ summenr, 2005.

My questions are [1] has anyone participated in the trial and what has been their experience including side-effects and [2] does anyone have any updated information on FDA approval.

Thanks
Barry

I may or may not be of any help. I'm currently in an Iressa trial. Being part of a trial means signing up for years of "study" It was also presented to me as a drug with few side effects, but I must say that in hindsight, I've been unlucky enough to experience some of them and would say that the word "minor" wouldn't qualify at the time I was experiencing them. However, whenever you the patient are experiencing side effects, the doctors do seem to take this as an encouraging sign that the drug is working.

Being part of a study or trial also involves more testing as being part of the requirements. At the time I signed up I asked if this would involve more blood draws or other painful procedures and was told "not really more than the usual" but sometimes it certainly feels like I have more fooling around with simply because of the trial. As a patient taking a trial drug you also have to fill out paperwork every day to note the exact TIME you took the drug, and the researchers in charge of the trial will call you up regularly to keep up with the paperwork and making sure you get in for the CT scans and bloodwork.

In all honesty, when I first got diagnosed and was facing this horrible disease head on, I was willing to take on anything that would improve my life expectancy. I willingly signed the contracts to be a part of a trial. Take the time to read over the contracts and talk to your doctors. When the radiation oncologist mentioned that the researchers will follow me up for two years and then five years out, that sounded pretty encouraging at the time. Also, it sounded good just to have an extra treatment in the arsenol against cancer at the time.

Good luck to you in whichever choice you make.

Jen

Barry, the linked article detailes all noted side effects in the study, and includes the safety warning.

http://www.forrelease.com/D20040605/nysa014.P2.06042004233942.04295.html

I don't believe anyone on the forum has yet been treated with Erbitux. If you are the first, you can educate all of us.

For the record, I was diagnosed stage 4 with mets to nodes more than three years ago and am just fine now. Do not panic, even though the tendency is to do just that. Lots, and lots of us made it though treatment and you will too.

Hi Barry.

I am sorry to hear of your SCC diagnosis. I participated in a Phase II trial of Erbitux. See my post under "Medications, Treatments, Procedures" in thread "No more treatment..." on June 26. I was responding to a question from Michael. There are ongoing scans and requirements, but they are not extraordinary. If I can answer further questions about my treatment let me know. You are in my prayers.