Starting on Lapatinib Clinical Trial on Friday

[Nicola]

Hi Everyone,

Just wanted to give a update. I am starting my chemo treatments on Friday, a combination of Zometa, Herceptin, Taxol and Lapatinib for mets in the liver and spine.

Zometa will be given once a month to strengthen my bones, Herceptin 4mg/kg loading dose and then 2mg/kg given by IV injection will be given once a week, Taxol 80mg/m2 will be given once a week for three weeks then one week off, Lapatinib 1000mg tablets once a day will be taken everyday at home in pill form.

I am so grateful and very fortunate to be on the clinical trial of Lapatinib, they were only taking 20 people nation wide for this trial and I was the second one signed up for it. There will be no placebo's being given to these first twenty participants (Open Label Phase) but my understanding is that in several months another trial (Randomized Phase) will begin where the participants have a 50/50 chance of actually receiving Lapatinib as opposed to a placebo but the first twenty participants that were signed up for the trial I am in will never receive a placebo.

List of drugs that CAN'T be taken while in the clinical trial are:

Antibiotics
Anti-fungals
HIV treatments
Anti-convulsant drugs
Calcium channel blockers
Anti-depressants
Gastrointestinal blockers

Possible Side Effects from Lapatinib

Nausea
Diarrhea
Fatigue
Rash
Weight Loss
Headache
Vomiting
Fever
Shortness of Breath
Dehydration
Difficulty Sleeping
Flatulence
Stomach Cramps
Anemia
Loss of Appetite
Flu Symptoms
Facial Flushing
Mouth Ulcer
Powdery Taste
Abnormal Liver Function Tests

About 2 out of every 100 people who took Lapatinib had a problem with their heart not pumping effectively around the body.

About 1 out of every 100 people who took Lapatinib had a problem with their lungs not working properly (called interstitial pneumonitis).

8 people in Lapatinib studies have died from taking the study drug.

There are small amounts of a chemical from a class of chemicals called "Chloroaniline Compounds" in Lapatinib. In laboratory tests, this chemical by itself caused changes to genes (DNA) that showed that the chemical has the potential to cause cancer or tumors. Exactly what these results mean about your risk in taking Lapatinib is not known. Researchers think that the risk of harm to you is low because:

When Lapatinib was tested in the same laboratory tests when Chloroaniline Compound was tested alone, the tests did not show that Lapatinib damaged genes.

Many cancer drugs have the potential to damage genes, but doctors believe that the possible benefits to cancer patients who take these drugs are greater than the risk of the drugs.

Cancer drugs with the potential for damaging genes include drugs which are being given with Lapatinib in this study and/or those you may have previously received in your cancer treatments.

Sponsor of the trial is: GlaxoSmithKline

My Study Doctor: Maura Kelly Hagan MD
Virginia Cancer Institute
6605 W. Broad St., Ste. B, Richmond, VA 23230

This is most of the information I was given about Lapatinib when I signed up for the trial. I will keep you all posted on my progress as much as possible and answer any questions that you may have when I can.

Big Hugs,
Nicola

[Rupali]

I wish you all the best Nicola. May you come out victorious and may Lapatininb be the future cure.

[newgg]

Super news for you to be involved with this research and this super med. You set the standard for all of us. Way to go Warrior !

[RhondaH]

and God Bless!!!! Keep us updated on the results.

Rhonda Hoffman

[Julie2]

It is very nice of you to share the information with us. I wish you all the best and quick recovery.

Julie

[karenann]

That is wonderful news. I am so happy for you!

God bless,

Karen

[al from Canada]

Dear Nicola, (warrior princess and protector of the small molecule invaders)


You are truly a warrior and an explorer! It is from people like yourself that the rest of us will learn and benefit. Trials and there entries are all a matter of timing: the right place with the right prognostic / diagnosic information required and time; it takes courage to make the time for these trials.

Linda and I wish you the utmost success with your treatment and thankyou for pushing the envelope. Who knows, 10 myears from now they will be singing songs of praise to the "first 20" as they were at SABCS and the "first 20".

I think this combination has excellent opportunities for success and I truly believe you have made a smart therapeutic decision. Please pay close attention to the "do not mix" items because they refer to the cytochrome 450 mediated metabolism that was discussed last week. aka grapefruit juice is a no no! as is everything else on the list

Go to this discussion to clarify this interaction:

http://her2support.org/vbulletin/showthread.php?t=21808

Take care and good luck,
Al and Linda

[Nicola]

Thank you so much everyone for your kind words of support and encouragement, I can't tell you how much it means to me.

I am a little nervous about receiving my first treatment but I am sure everyone feels this way at the beginning. It is the fear of not knowing how you will respond to the meds. It is just one day at a time and a lot of faith.

Can anyone tell me how it feels when they first access the portacath and how it feels when the drugs are first administered, is there burning sensations etc.? They told me the entire treatment should last for about four hours the first time and then 3 to 3 1/2 hours there after. I am sure I will be getting a lot of reading done during the treatment which is always a plus. Is anyone ever able to nap during it? I used to have a phobia of needles but after becoming a human pin cushion that is gone but I still hate the finger pricks for blood check-ups, lol.

Thanks so Much,
Nicola

[karenann]

Nicola,

For the port, my nurse prescribed a numbing cream, which I put on about an hour before my treatment. I use it everytime I have chemo and I can't feel a thing, so ask your doctor about it for your next treatment.

As far as the drugs go, Taxol gave me bone pain, but I had it every two weeks, not weekly, so my dose was bigger than the one you will be getting. The only problem I have with Herceptin, is mild fatigue the next day.

Best of luck to you. I just know you are going to do well and have great success with these drugs.

Karen

[al from Canada]

Nicola,

If you are getting Taxol then you are also getting pre-meds; one of them an anti nausant (which will probably put you asleep.) I would ask them for some ativan just to take the edge off because it is stressful....probably more-so for me when I watched.. I remember talking to Linda about it when she was getting her first and the apprehension was anti-climactic. Have some bendryl and gravol at home just in case. Herceptin may make your nose run but the hype far exceeds anything you'll probably experience.
We are all proud of you and as we say in the Great White North, "eatem raw!!"
Al

[Patty H]

I love my port and I also use a numbing cream at least an hour before I have treatment and I feel nothing. When I have forgottent the cream it stings a little when they insert the needle but other then that I don't feel any discomfort form the chemo going in. I'm really excited to see someone getting labpatinib. I keep hoping it will be approved soon. My Dr. thinks it might be the drug for me. So keep on keeping us informed. best of luck Patty H

[lexigirl]

Nicola,
Just a note to let you know I am thinking of you and saying prayers for you and all of us Her2neu ladies.

God Bless You,

Lexi

[StephN]

Hi Nicola -
As you know the purpose of getting port is to save your veins as the chemo can wreck them in short order.
I have had my port for over 5 years now and it still works just fine. I never felt ANYTHING, even with the 27 (yes, twenty-seven) infusions of taxol and navelbine to get me to NED. Also, had Herceptin along with all that, of course, and still get Herceptin each 3 weeks.

The end of the port catheter is down into a main vein leading into your heart, so there is little vein area exposed for the drugs to affect. The drugs go straight into your bloodstream and are dispersed quickly. That is why in my case I would feel the effects first in my mouth. Tongue would get dry and bothered so I would eat ice or a popsicle to slow the bloodflow in my mouth. This way I did not have such bad mouth sores from taking such long treatment.

I have another question about the trial.
Is there a set time or are you just on the treatment either until you are showing disease progression (drugs not working) or have remission or complete response?
This is the way it was for me in my trial to "GET" my mets. I was the first one through with a complete response, so take it from me that you CAN do this and get there!
Onward to wellness!

[Nicola]

Thanks Al & Everyone for the great info and support. I wish I could hug you all.

I just found out this morning that I am now going to be the first person on this clinical trial, YIKES! The women who signed up first unfortunately pulled out due to other health issues. I don't know if I should be nervous or excited, I guess I am little of both. I will let you all know how it goes.

I wish you all a very Merry Christmas & Happy New Year!

Hugs,
Nicola

[Cathya]

Nicola;

I am so excited for you!! I will be praying and thinking of you and watching for your posts. I can imagine you have mixed feelings about all this but remember that Dr. Sloman thinks this drug will be better than Herceptin! Imagine that. They will be watching you like hawks and you'll get better care than anyone on normal treatment. You deserve it too! God bless.

Cathy

Dear Nicola,

You go girl; you deserve the best after your DCIS underdiagnosis. I concurr with the previous post that Dr. Salmon thinks Lapatinib is stronger than Herceptin against the Her2 pathways. I'm praying for you and look to your results with optimism and hope .
Fondly,
RobinP

[TriciaK]

We are all so excited for you, Nicola! You truly are our warrior princess in the forefront, and we will be watching for every post. 2006 will be a great year! Have a merry Christmas, and know you are in our thoughts and prayers! Hugs, Tricia

Hi Nicola,

You are in my thoughts and prayers as you start your new treatment today.

Just for the record, I, too, have had a port for 5 years and it's still doing fine. It's become a "part of me" and I don't even notice it at all. I know the idea sounds scary but I can't imagine taking chemo any other way. I, too, use numbing cream or EMLA patches (you need a prescription from the oncologist for this) that you stick on top of the port like a big bandaid about 30 min - 1 hr before. You don't feel a thing. I've even forgotten to use the cream many times during the last 5 years and in fact, the "prick" itself is nothing more painful than the prick you feel when you get your blood drawn, at least for me.

I was wondering if you had the exact title (and number) for the trial you're starting today. I tried to find it on the Internet but didn't have any luck. I was curious about the exact inclusion and exclusion criteria are for this trial.

You're in all our hearts and prayers today.

Love,
Kay

[kristen]

Dear Nicola,

You go girl!! I wish you the best. And one means "new beginnigs". My hope for you, in this slot, it is all that and much more. Have a Happy Holiday and please keep us posted.

[Nicola]

Hi Everyone....

Wanted to let you know how my first treatment went.

I was so eager to get started on chemo, I couldn't wait to start doing something to attack this horrible disease. I was so nervous though yesterday but luckily it all went well. It didn't hurt when they accessed my portacath, they sprayed it with freezing spray first, my port is on my left side the same side as my lumpectomy, I figured I might as well have one good breast left, lol. The Zometa made me achy and the anti-nausea meds mixed with the steroids made me feel a wee bit tipsy for a while and then very sleepy, I was actually able to nap through some of it. It was a very long day, we got there at 8:30 AM and didn't leave until 3:00 PM. The Zometa and Anti-nausea meds didn't take long to administer and once the Zometa was in I was able to take the Lapatinib by mouth in pill form but the Herceptin took forever, the Taxol took about an hour. They had to give me a loading dose first of the Herceptin and then the port acted up and it took a little while to get it going again before the Taxol could be given. It seems that the best position to be in for my port to work properly is flat on my back. When I got home I felt tired and achy like when you are about to come down sick. I went straight to bed for a nap and when I woke up I felt pretty good. So far this morning I am still feeling well but a little tired.

I will have chemo once a week on every Friday but will take the Lapatinib everyday at home in the mornings. If this is all of the side effects I will experience besides losing the hair it wont be so bad. I am sure I will have some bad days but overall I think it will go well.

I can't thank you all enough for your prayers and support. I will be sure to keep in touch and let you know how I am doing.

I hope you all have a wonderful Christmas and a Happy New Year.

Big Hugs,
Nicola