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