Wanted: Clinical Trial Info

hope · 10-04-2005, 12:18 PM

If you read my update above, you know that Dr. Pegram suggested I go on a clinical trial. I am seeking info on anyone who has gone on one, because I'm very afraid but also know that this might be the only thing left for me. Here are some questions that maybe some of you can help me with.

Where you scared to go on a clinical trial?

What made you decide to go on a clinical trial?

What phase? Dr. Pegram said that right now at UCLA I only qualify for phase I/II

Did you have any complications?

How long were you on a clinical trial?

If you stopped being on trial why?

If you are still on a trial, how long have you been on it and is it working?

Those on a phase III trial were you ever told that all phase III trials are blind studies and generally for first line treatment and not metastatic disease?

The study that I am possibly eligible for at UCLA is BMS-599626. It's supposed to target Her2Neu/EGFR. It is a phase I however, it will be a phase II for me because toxicity levels have been reached and they just have to compile the data. The study design is available on the NCI website. I hope some of you can ease my anxiety about clinical trials. God Bless, Hope

Lolly · 10-04-2005, 02:02 PM

Hope, I was in the UW/Seattle Her2 vaccine trial. I'm sorry to hear you're struggling so with those mets and your decision on your next course of action. I think you're going through the right process: get as much info as you can about options, let everything kick around in your mind for awhile, and then gradually you'll know what course to take.

The vaccine trial I was in was Phase I-II, and I was able to stay on Herceptin while I got the vaccine, which eased my mind. I would have been very nervous to go off Herceptin to do the trial, and probably wouldn't have gone ahead if that were the case. But since I COULD continue Herceptin, I felt I had nothing to lose in getting the vaccine and it may well prove to help keep the cancer controlled. Also, it will help other people down the road.

I've had no complications so far; I have a MUGA coming up which will show if my heart function has decreased, which is one of the main unknowns about the vaccine in conjunction with Herceptin. This was the aspect which made me a bit nervous about this study, but I just kept up with my CoQ10, with the study doctor's ok, and kept my fingers crossed. We'll see how that went soon.

I had six vaccines, over a period of six months, and follow-up blood work at the 7th and 9th month, this being the 9th month. I was to have more blood work at the 12th month, which would finish up the main data collecting part of the trial, then I was to be followed annually with a questionaire filled out by my onc, but I HAVE had a recurrence confirmed last week to axilla lymph nodes, and have started chemo again. So technically, I'm out of the trial although when I contacted the study doctor to inform them of my status, she said they would still be keeping tabs on me and using my information in other ways, so we're staying in touch with them as it's possible there will be another trial I'll qualify for when done with this round of chemo.
It's felt that the vaccine may continue to "work" even with the addition of chemo. Time will tell.

If the Phase I part of the BMS etc. trial is completed, that means safety has been established, correct? So the Phase II trial will be to establish dose levels; if I understand the process correctly they will gradually escalate the doses? I'm sure the thought of possible side effects makes you nervous, but remember they'll be watching you very closely and you will be at one of the best cancer facilities in the nation.

Good luck with your decision,Hope. Let me know if you have any more questions.

<3,
Lolly

Shell · 10-05-2005, 05:29 AM

Hi Hope-

I cut and paste your questions so I wouldn't forget them. Here are my thoughts...

Where you scared to go on a clinical trial?
-The concept can seem scary, but I viewed it as a chance to be at the forefront to receive new treatments that might help me...

What made you decide to go on a clinical trial?
-The treatment my doctor recommended for was xeloda. I saw a Phase III clinical trial that used xeloda, and a drug being tested, lapatinib, that is potentially able to work on those of us who have failed herceptin. No local hospitals offer the trial, so I travel about 1 1/2 hours to participate in the trial.

What phase? Dr. Pegram said that right now at UCLA I only qualify for phase I/II
-This phase III trial is designed for stage IV patients without brain mets.

Did you have any complications?
-No. I am in the arm getting only the xeloda, so it is the same treatment I would have been getting had I stayed with my regular onc for it. The selection was randrom, and when they learned I didn't get in the arm w/ the xeloda and the lapatnib, some assumed I would skip the trial. But I want to see people enrolled in it, to complete it, to see if it works. The more of us who join the trials in that regard, the sooner some of these successful drugs will be available for use....

I've had side effects from the xeloda, but I would have had them regardless, as that would have been my treatment anyway.

How long were you on a clinical trial?
-I felt the progression in March, and it took several months for the scans, etc. to be read, and for me to learn about the trial. The difficult part was getting all of my records together for a new doctor/hospital. But everyone was very helpful, and I started at the end of June.

I'm still on it, and get scans every six weeks or so.

If you stopped being on trial why?
-I'm still on it...

If you are still on a trial, how long have you been on it and is it working?
-Since June, and my scans have shown progress to date...

Those on a phase III trial were you ever told that all phase III trials are blind studies and generally for first line treatment and not metastatic disease?
-Mine is random, not blind. That means that I knew ahead of time that I was not getting the study drug. Each trial may have different goals and objectives. Should this Phase III trial work on those of us with mets, presumably down the road it would also be considered for early stage as well...

Good luck with your decision...

Kind regards,
Shell

mamacze · 10-05-2005, 06:51 AM

Dear Hope,
I too was in the same trial as Lolly; I have nothing more to add other than it gave me great peace of mind.
You are doing the right thing; the more information you gather, the more options you have, the more peace you feel.
Love,
Kim from CT

StephN · 10-05-2005, 01:30 PM

Good afternoon Hope -
Glad your news is at least mixed and NOT showing that you are doing worse. You have had so much to endure this past year. I hope you are feeling better other than the Abraxane effects.

When I joined a clinical trial for hard-to-treat mets it was a trial where we all got the Taxol and navelbine and it was to define the tolerated dose - phase II.

My mets had come so fast and furiously that I really had no other choice for treatment at that time. Until I failed this trial we did not want to try Gemzar which was also in trial then. Turned out that I did not need to go there, as the blast of drugs that I took worked on my mets.

It WAS very scary, but I had NO time to think about it. I was diagnosed with the mets and was presented with the trial within the same hour. One hour later I was up in infusion suite GETTING the drugs, as well as my first loading dose of Herceptin. It was more like getting swept off my feet.

Not really until the next day did the whole thing set in. But, I got such super support from my family and friends as the news travelled. The prayers were sent up but I had no idea what would happen to me.
I also had appts the following two days for futher evaluation - a bone scan then a brain MRI. As I "passed" those without significant findings, I felt a little better that the disease was contained to my liver and only starting into my bones. With a clear brain scan I could stay on the trial and give those drugs a chance to work.

The rest is history and I am still NED. It was not easy to tolerate those strong drugs, and I was very weak for quite a while. But, the fight was in me and still is.
So keep your shield polished and your sword sharp - you will make it.

michele u · 10-05-2005, 08:36 PM

Hope,

I think clinical trials get a bad rep from the media. They will pick out the one in a million side effects and play them up. I'm a nurse, so i know this happens. I was in 2 clinical trials. First being the Herceptin adjuvant trial for a year, and look, now it is front line. the second being the Her2 vaccine trial. I think clinical trials give us great hope and a chance to get treatments NOW that won't be out for a while. this gives us the best chance of surviving this. Younger people do go for clinical trials, i think because we have more aggressive cancers, and there isn't a given treatment now that can cure us. Don't be afraid of them. If it will cure only one in 1,000 patients say, who knows that you aren't that one?