Lapatinib EAP

[Ragini]

Hi,
I have asked the same questions on some of the other boards as well.
Is there anyone who has started taking the lapatinib Xeloda combo on the Eap program. I understand that it started sometime End July. It has not come to singapore yet and am trying to get my self enrolled into it at one of the centres in LA where my sister lives. I talked to the coordinator of appoints gave a brief history and faxed in all the copies of resulots and scans she had requested on 23rd Aug. I have not heard from her. I have sent her an email with more or less similar questions that I am posinng to you. I have been on different regimens of chemo since my recurrence in Oct 2000 without remission or a break. I seem to have exhausted the list of chemos and probably have to recycle the taxanes or anthracycline. I am desperately tryng to gert on the Eap but I think my insurance will not cover the follow up costs. The questions are as follows




What are the tests and/or scans which need to be done prior to the first appointment with the MD?
Is it OK if the scans, for example, are done here in Singapore and I bring the results to California for reading?
3. Which tests would have to be done in California itself, and what would they typically cost?
4. Should I be Lapatinib EAP

accepted for the EAP, how frequently would I be expected back for check-ups after the initial appointment and what sort of tests/scans would have to be done during such check-ups?
5. This would make life a whole lot easier with my insurance claims.
What are side effects you are experiencing so far?

I hope you all have a wonderful response. Any answers from you guys is much appreciated. Thank you and big hugs,

Ragini

[mts]

Ragini,

I think you may get more responses if you post your questions in the Her2group forum instead of the Clinical Trials forum.
I too am curious to the responses.
Warmly,
Maria

[Theresa McNiel]

Ragini:

1. Scans and reports you will need (latest scans have to be relatively recent, if they are too old you will need to do them over):
- pathology reports from all surgeries/biopsies
- latest CT scans (actual films plus reports)
- latest echo/EKG reports
- latest blood tests
- medications list (from your oncologist showing dates/doseages of all chemos/drugs you have been on)
-any other scan reports (PET, MRI, ultrasound)

You must check with the actual physician who is the contact at the EAP site you wish to visit (I gather since you want to be in LA that would be Dr. Link at Breastlink Medical Group, Long Beach, tel: 562-427-2100, or Dr. Mena, Providence St. Joseph Hospital, Burbank, tel: 818-840-0921) to see if your S'pore scans/records are acceptable.

2. You will have to report back to the doctor in LA once every three weeks for the duration of your treatment. They do labwork every three weeks and heart echo every six weeks. Don't know what other scans are required.

Ragina, the procedure is you consult with the doctor then he/she refers you to the research office he/she is associated with. They enroll you in the EAP and give you the drugs. So you will want to speak BOTH with the doctor's office and ask for the research office to make sure they are all coordinating on your case.

Best of luck to you. My hubby is Singaporean and I used to live there too. My dream is to go back to S'pore to visit my in-laws early next year, since it has been two years since I was there. Your oncologist may need to do some follow-up phone calls after you do the initial calls but BE PERSISTENT, don't wait for a response. I had to bug the EAP site in Santa Rosa, CA for about 6 straight days before I got any kind of answers out of them.

Regards,
Theresa in Hawaii

[Ragini]

Hi Theresa,
Thank you for all the info. I sat up pastmidnight to contact the LA clinic and the research coordinator told me that the Dr. incharge was out of town for a couple of days and that she will definitely respond to all my queries by the end of this week. I am keeping my fingers crossed for it to happen soon. In the meanwhile have to wait patiently. Hope you keep posting about your experience with Tykerb. Would be nice to meet up or chat on the phone when you come to Singapore again. With lots of hugs.

Ragini

[mkrny]

My wife should be starting Tykerb/Xeloda EAP Wednesday, 10/11 on Long Island in NY. We provided full history and she has completed scans/tests that they request are done w/i 14 days of starting the EAP
1- pregnancy (for obvious reasons)
2- MUGA & ECHO to confirm heart function.
3- CAT of chest/ab/pelvis and bone scan for a baseline
My wife has brain/CSF mets and had an MRI the middle of last month that was acceptable as baseline for brain and spine

Details on this trial (EGF103659) can be seen at http://www.trialcheck.org/cancertrialshelp/cancertrialshelp.aspx?intAppMode=3&intProtocolUID=22362

Ken & the other Maryann