Tarceva Clinical Trial Information

Q. What is a clinical trial for patients with cancer?

A clinical trial is medical research conducted in a clinic to determine if new cancer treatments are effective and safe. A clinical trial involving human subjects is one of the last steps in a long and careful process. Researchers often study their ideas in a laboratory for years before a new treatment is tested in cancer patients.

Q. Why are clinical trials important?

A. Clinical trials are important in helping doctors and researchers learn more about cancer and can lead to more effective treatments and care. If a treatment works well in a clinical trial, it may be approved as a new standard treatment and help many cancer patients.

Q. Are there different types of clinical trials?

A. Clinical trials are done in a series of steps called phases.

Phase I

Phase I trials are early studies intended to find out the amount of the drug that works best and how much can be given safely. A small dose is given and then gradually increased while doctors watch closely for unnecessary side effects.

Phase II

Phase II trials also test the safety of the treatment and seek to determine if the treatment is effective. If the treatment works, doctors will plan a Phase III study. If the treatment does not work, no further trials will be conducted.

Phase III

The goal of Phase III trials is to find out if the new treatment is more or less effective than the standard treatment. Phase III trials involve a larger number of subjects and are the type of trials that cancer patients most often join.

Q. What is a randomized trial?

A. A randomized trial is a study in which patients are put into a treatment group by chance. One group will receive the new treatment being studied and the other will receive the standard treatment.

Q. What is a single-blind trial? A double-blind trial?

A. In a single-blind trial, either the patient or the doctor knows which treatment group the patient is in. In a double-blind trial, neither the patient nor the doctor knows which treatment group the patient is in. Blinded trials are intended to make sure that the results are not biased by anyone's hopes for a certain treatment.

Q. Who can join a clinical trial?

A. Every clinical trial has a list of features - called "eligibility criteria" - that a patient must meet to be able to join the study. These may include age, gender, or type of cancer. Eligibility criteria help doctors determine which patients may be helped the most if a treatment works.

Q. Should I take part in a clinical trial?

A. Once you have qualified for a trial, only you can decide whether to join the study. Before doing so, you should:

Learn as much as possible about your disease.
Ask your doctor what clinical trials are open to you; you can also contact the National Cancer Institute (NCI), National Institutes of Health (NIH) and the American Cancer Society (ACS).
Discuss your feelings about clinical trials with your doctor, nurse, family members and friends.

Q. What type of trial was Tarceva's approval based on?

A. The effectiveness and safety of Tarceva in combination with gemcitabine as a first-line treatment was tested and proven in a randomized, double blind Phase III trial involving 569 patients. These patients had locally advanced, unresectable or metastatic pancreatic cancer.

Q. How did Tarceva (erlotinib) perform in large clinical studies?

A. Tarceva (erlotinib) has been shown to help some patients live longer. In a large clinical study, 23.8% of patients who were taking Tarceva (100mg) plus gemcitabine were living with their pancreatic cancer one year after they started this treatment, compared with 19.4% of patients receiving gemcitabine alone. Additionally, large clinical studies have also proven that Tarceva can slow or stop the growth of cancer cells in some patients.

To find additional clinical trials for Tarceva, please visit www.clinicaltrials.gov

Indication and Usage for Advanced Pancreatic Cancer Patients

Tarceva in combination with gemcitabine is prescribed for patients with advanced-stage pancreatic cancer who have not received previous chemotherapy.

Important Safety Information

Possible effects on the lungs

In clinical studies, there were infrequent reports of lung injuries similar to Interstitial Lung Disease (ILD)-like events in patients taking Tarceva for the treatment of pancreatic cancer or other advanced solid tumors. Reports of these ILD-like lung injuries have been serious and have included deaths in some patients.

Possible effects on the kidneys and liver

Liver and/or kidney problems (including deaths) have been reported in some patients taking Tarceva. Let your doctor know if you have a history of liver or kidney disease.

Possible effects on the stomach and intestines

Holes that formed in the stomach, small intestine, or large bowel (including deaths) have been reported in patients taking Tarceva.

Possible effects on the skin

Severe blistering skin reactions including cases similar to Stevens-Johnson syndrome (including deaths) have been reported in patients taking Tarceva.

Possible effects on the veins and heart

Patients taking Tarceva plus gemcitabine were more likely to experience bleeding and clotting problems such as heart attack or stroke.

Possible effects on the eye

Eye irritation and damage to the cornea have been reported in patients taking Tarceva. Patients should tell their doctor about eye problems, including eye pain, that get worse.

Tarceva and pregnancy and breast-feeding

Tarceva may cause harm to an unborn baby or may cause possible risk of pregnancy loss. Women should avoid becoming pregnant and avoid breastfeeding while taking Tarceva.

When to call your HCP

Call your doctor right away if you have these signs or symptoms:

New or worsening skin rash
Serious or ongoing diarrhea, nausea, loss of appetite, vomiting, or stomach pain
New or worsening shortness of breath or cough
Fever
Eye irritation

If you smoke, you should stop smoking while taking Tarceva, as it may affect how well Tarceva works for you. If you continue to smoke you should speak to your doctor before taking Tarceva.

Let your doctor know if you are taking other prescription or over-the-counter drugs or herbal supplements before you start taking Tarceva. While taking Tarceva, do not start taking any new drugs or herbal supplements before talking to your doctor. Do not eat grapefruit or drink grapefruit juice while taking Tarceva. Tarceva may also affect other medications you are taking.

Common side effects of Tarceva

Fatigue, rash, nausea, loss of appetite, and diarrhea were the most common side effects associated with Tarceva plus gemcitabine therapy in a large clinical study.

Always let your doctor or nurse know if you experience any side effects. Ask your doctor or nurse for the best way to handle drug-related side effects.

Tarceva is not right for everyone. Ask your doctor if once-daily Tarceva is right for you.

Please see the Tarceva full prescribing information for complete safety information.