Help - Phase 1 clinical trIAL

[clisa]

Well today was not a good day - the results of my recent ultrasound showed increased growth of my existing tumours and new tumours in my liver. I have just completed 3 sessions of Xeloda. Prior to this I have received taxol, herceptin, carboplatin and AC regimens with no positive results.

Today I am told I am running out of options - my oncologist says she could try navelbine with herceptin but there is only a 10-15% chance of that working.

I have been offered a chance to participate in a Phase 1 trial for ARRY-334543. Is anyone familiar with this drug? It feels like my last chance.

Getting really scared here - surgery and radiation are not options because of the amount of tumours. It is only 8 months since my intial diagnosis and this is going way too fast.

Anyone got any advice? I am in Canada so lapatinib, avastin and abraxane are not options. I should be happy I feel great for someone who is so sick - showing no symptoms of liver failure even though my largest tumour is 7cm now. Hard to beleive this is happening to me.

Help please.

Lisa

[al from Canada]

Dear Lisa,

Adding navelbine to the mix certainly will increase cyto-toxicity. Xeloda + navelbine + herceptin is an excellent combination! This could be your lucky day because, as I was reading your post, I was thinking ERB-1 and here you are: offered a trial with just that! This sounds like a very interesting study and the drug sounds like it could be a cousin of lapatinib, which is also an HER1 & HER2 inhibitor. The question is: can you get this drug WITH herceptin? I don't know if this matters but lapatinib has shown expodentially increased effacy when combined with herceptin. Also, will you be able to continue at least one cyto-toxic drug; like xeloda or navelbine, with the ERB inhibitor??

I know you are scared to death but: you must give this your best shot! Two reasons herceptin fails are #1, HER2 has a low over-expression and #2, the cancer sneaks through the back door as in the ERB-1 pathway.

I would consider the doing one of the following:

1. consider taking the HER2 serum test. I don't know if it is available in canada but it would give you and indicator of HER2 activity
2. find out your IHC and / or fish results fron your primary tumor, are you really a candidate for herceptin? If not, there is a very successful trial combining taxol and avastin (E-2100) you could consider
3. If you are strogly HER2 over-expressed, that is one more reason why the trial drug would probably work in you. Given your tumor load, I'm not convinced I would totally abandon the xeloda or navelbine.
4. can you get tested for VEGF over-expression? This would indicate if you would respond to avastin. Lapatinib is not approved therefore is not available outside of clinical trials. Avastin is approved for CRC therefore you may be able to get it "off-label"
5. If you really feel things are spinning out of control, call a U.S. center and get a second opinion asap. The five that immediately come to mind are: University of Philadelphia (Dr. Kathy Miller); Dana Faber (Dr. Eric Winer); UCLA (Dr. Mark Pegram); University of Washington State, (Dr. R. Livingston);and Cleveland Breast Cancer clinic.

You have taken a step in the right direction by finding this Board as there are may others here who have already walked in your shoes.

Good Luck,
Al

ps, where in Canada do you live?



From Canada you say?

[sherri]

Lisa,
Where in Vancouver do you live? Do you go to BC Cancer Agency? Who is your Doctor? Send me an e-mail and see what we can do for you.

Just a quick correction to the names that Al gave you, all of whom are excellent and highly respected. Kathy Miller is at the University of Indiana, not Philadelphia.

As for the 10-15% percent number, I don't see how they know for sure, and if you are in that group, then it is 100% for you.

No one can tell you when to stop. Only you can make that decision.

good luck,

we are all rowing in the same boat.....

[Esther]

Lisa, try to push for Navelbine, Xeloda and Herceptin. There were clinical trials presented at San Antonio in 2004, that that combination was syngergistic, and showed a higher rate of effectivenes than either agent alone.

I had that combo and I rebounded from liver mets so severe I was initially declared that I would be lucky to survive a year even with treatment.

2 years later and I have been NED for a year, and as active as ever.

[clisa]

Spoke with my oncologist today and here is an update:

1. have registered to start the erb inhibitor phase 1 trial - cannot get into the trial for about 4 weeks. In the meantime will be going through all the tests to get ready for this.

2. Will be starting navelbine and herceptin this week until my phase 1 trial starts.

3. Cannot get xeloda combined with the navelbine and hereptin becaus emy doctor feels that the chances of toxicity outweigh it's chances of success.

4. Making a # of contacts here at home and in the states to get 2nd opinions about past treatments and future options.

5. Cannot get avastin as it only has CRC approval for use in colon cancer and the clinical trial done on breast cancer last year showed poor results with breast cancer so was not approved for that.

6. signed up for a two day program with an integrated health treatment centre that has had very good results with cancer here in Vancouver.

7. staying strong, staying optimistic ... and staying healthy!

Thanks all for your help. Lisa

[al from Canada]

Dear Lisa

You have made great progress.....in reference to youe onc's comment of avastin not responding to BC (or the other way around,) I refer you to E-2100 or the post: http://her2support.org/vbulletin/showthread.php?t=22565
In terms of navelbine and xeloda....this is almost the Industry standard for MBC in ths US. 90% of the side effects will result from the navelbine! There are many women her who have been on the same combo with excellent tolerability.

One last question: is the HER2 serum test available to you?

As always,
Al