Related pages Drug Information Summaries 1 Approval Process for New Cancer Treatments 2 Access to Investigational Drugs: Q & A 3

This page contains brief information about capecitabine and a collection of links to more information from the National Cancer Institute (NCI), the Food and Drug Administration (FDA), and the National Library of Medicine (NLM).

US Brand Name(s):		Xeloda
FDA Approved:		Yes

Capecitabine is approved by the Food and Drug Administration (FDA) as adjuvant treatment for stage III colon cancer in patients who have had surgery to remove the cancer.

Capecitabine is also approved to treat metastatic breast cancer in patients whose disease has not gotten better during treatment with other drugs.

Capecitabine is also being studied in the treatment of other types of cancer.

Patient Information Sheet on Capecitabine ⁴ - A lay language summary of important information about this drug that may include the following:

• FDA warnings or alerts about this drug,
• what this drug is used for and how it is used,
• what you should tell your doctor before using this drug,
• what you should know about this drug before using it,
• other drugs that may interact with this drug, and
• possible side effects.

Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. This FDA patient information sheet applies only to approved uses of the medicine. However, much of the information may also apply to unapproved uses that are being studied.

FDA Approval for Capecitabine ⁵ - Information from the FDA about the approval of this drug and the clinical trials that led to the approval.

Definition from the NCI Drug Dictionary ⁶ - Detailed scientific definition and other names for this drug.

Clinical Trial Results: Combination Therapy and Advanced Breast Cancer (06/03/2006) ⁷ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Capecitabine an Alternative for Colon Cancer (07/27/2005) ⁸ - Important clinical trial results for this drug, background information, and how the trial was done.

MedlinePlus Information on Capecitabine ⁹ - A lay language summary of important information about this drug that may include the following:

• warnings about this drug,
• what this drug is used for and how it is used,
• what you should tell your doctor before using this drug,
• what you should know about this drug before using it,
• other drugs that may interact with this drug, and
• possible side effects.

Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. This NLM patient information sheet applies only to approved uses of the drug. However, much of the information may also apply to unapproved uses that are being studied.

Clinical Trials for Capecitabine ¹⁰ - Check for trials from NCI's PDQ Cancer Clinical Trials Registry now accepting patients.

Glossary Terms

Treatment given after the primary treatment to increase the chances of a cure. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, or biological therapy.

Cancer that forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare.

A term for diseases in which abnormal cells divide without control. Cancer cells can invade nearby tissues and can spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord.

FDA. An agency in the U.S. federal government whose mission is to protect public health by making sure that food, cosmetics, and nutritional supplements are safe to use and truthfully labeled. The Food and Drug Administration also makes sure that drugs, medical devices, and equipment are safe and effective, and that blood for transfusions and transplant tissue are safe. Also called FDA.

Cancer that has spread from the place in which it started to other parts of the body.

Tumor cells have spread to organs and lymph nodes near the colon/rectum. Also called Dukes C colorectal cancer.

A procedure to remove or repair a part of the body or to find out whether disease is present. An operation.