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Tarceva® erlotinib tablets
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Tarceva Clinical Trial Information

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The following organizations can help you find more information about clinical trials:


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

A clinical trial is medical research conducted in a clinic or hospital 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 treatment.

Q. What are the phases of clinical trials?

A. Clinical trials are done in phases. Each phase has a different purpose and helps answer different questions.*

Phase I trials

Researchers test a drug or treatment in a small group of people (20-80) for the first time. They evaluate its safety, find safe doses, and look for side effects.

Phase II trials

The drug or treatment is given to a larger group of people (100-300). They see if it is effective and safe.

Phase III trials

The drug or treatment is given to even larger groups of people (1,000-3,000) to make sure it is effective, monitor side effects, compare it to commonly used treatments, and see how the drug or treatment can be used safely.

Phase IV trials

After the drug or treatment has been made available, studies look for more information including the drug's risks, benefits, and how to use it best.

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. This is done to prevent bias that may weaken the trial results. If patients choose their own group, then their choices, beliefs, or any other factors than those being studied may affect the trial results.

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 an appropriate fit for the trial.

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. As maintenance treatment, Tarceva was tested in a multi-center, randomized, Phase III trial involving 889 patients. Patients were treated with four cycles of standard first-line platinum-based chemotherapy and then randomized to Tarceva or placebo if the cancer did not progress.

As a second-line treatment, Tarceva was tested in a randomized, double-blind Phase III trial involving 731 patients. These patients had advanced non-small cell lung cancer and had been through at least one other chemotherapy treatment that had failed to help them or had stopped working.

*Adapted from the 2007 "Understanding Clinical Trials" FAQs.1

Indications and Usage for Advanced Non-Small Cell Lung Cancer Patients

Tarceva is prescribed for patients with advanced-stage non-small cell lung cancer (NSCLC) whose cancer has not spread or grown after initial treatment with certain types of chemotherapy (maintenance treatment).

Tarceva is prescribed for patients with advanced-stage non-small cell lung cancer (NSCLC) whose cancer has spread or grown after receiving at least 1 chemotherapy regimen (second/third-line treatment).

Tarceva is not meant to be used at the same time as certain types of chemotherapy for NSCLC.

Important Safety Information

Possible effects on the lungs

There have been reports of serious adverse events involving the lungs in a small number of patients taking Tarceva. These events have included death in some patients. The medical name for these types of events is interstitial (in-tur STISH-ul) lung disease-like events (or ILD-like events).

Possible effects on the kidneys and liver

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

Possible effects on the stomach and intestines

Some patients taking Tarceva have developed a hole in the lining of their stomach or intestines (including deaths).

Possible effects on the skin

Some patients taking Tarceva have developed serious skin conditions. Some patients have died from these conditions.

Possible effects on the eye

Some patients taking Tarceva have developed eye irritation and damage to the cornea. Patients should tell their HCP about eye problems that get worse, including eye pain.

Tarceva and pregnancy and breast-feeding

Women should not become pregnant while on treatment with Tarceva. DO NOT breast-feed while receiving treatment with Tarceva.

When to call your HCP

Call your HCP 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

Before you start taking Tarceva

Some patients taking Tarceva have experienced difficulty with blood clotting, and bleeding events, including gastrointestinal and non-gastrointestinal bleeding. Patients taking blood thinners (Coumadin®, warfarin or other coumarin-derivatives) should be monitored regularly.

Taking other medicines and herbal supplements with Tarceva

It is important that you tell your HCP about all of the medicines and herbal supplements you are taking. DO NOT start taking any new medicines or herbal supplements before talking with your HCP. Tarceva may also affect other medications you are taking.

DO NOT eat grapefruit or drink grapefruit juice while on treatment with Tarceva, except under the care of your HCP.

Smoking

Smoking may affect how well Tarceva works for you. If you smoke, you should stop smoking before starting treatment with Tarceva. Talk with your HCP about how to quit smoking. If you continue to smoke, you should talk to your HCP before taking Tarceva.

Common side effects of Tarceva

The most common side effects in patients who took Tarceva were mild to moderate rash and diarrhea. You may also have other changes in your skin.

Hair and nail changes have been seen with Tarceva.

Always let your HCP know if you have any side effects, and ask about the best way to handle them.

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

  • 1. "Understanding Clinical Trials." ClinicalTrials.gov. U.S. National Institutes of Health, 09 September 2007. Web. Accessed 24 May 2010.

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