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

This page contains brief information about gemcitabine hydrochloride and a collection of links to more information about the use of this drug, related research results, and ongoing clinical trials.

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

Gemcitabine hydrochloride is approved by the Food and Drug Administration (FDA) to be used by itself to treat pancreatic cancer that is advanced or has metastasized (spread to other parts of the body). It is used in patients who cannot be treated with surgery and have already been treated with other chemotherapy.

Gemcitabine hydrochloride is approved to be used with other drugs to treat the following:

• Ovarian cancer that is advanced and has not gotten better with other chemotherapy.
• Breast cancer that has metastasized (spread to other parts of the body) and has not gotten better with other chemotherapy.
• Non-small cell lung cancer (NSCLC) that is advanced, cannot be treated with surgery, or has metastasized (spread to other parts the body).

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

FDA Approval for Gemcitabine Hydrochloride ⁴ - 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 ⁵ - Detailed scientific definition and other names for this drug.

Clinical Trial Results: Treatment Regimen Extends Survival for Women with Cervical Cancer ⁶ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Combination Treatment Boosts Survival in Biliary Tract Cancers ⁷ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Gemcitabine Plus Carboplatin Benefits Women with Recurrent Ovarian Cancer ⁸ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Gemcitabine Plus Standard Chemoradiation Improves Survival in Patients with Pancreatic Head Tumors ⁹ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Gemcitabine after Pancreatic Cancer Surgery Improves Survival ¹⁰ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Erlotinib Plus Gemcitabine Boosts One-Year Survival in Pancreatic Cancer ¹¹ - Important clinical trial results for this drug, background information, and how the trial was done.

MedlinePlus Information on Gemcitabine Hydrochloride ¹² - 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 Gemcitabine Hydrochloride ¹³ - Check for trials from NCI's PDQ Cancer Clinical Trials Registry now accepting patients.

Glossary Terms

Cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment.

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.

Treatment with drugs that kill cancer cells.

Any substance, other than food, that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition. Also refers to a substance that alters mood or body function, or that can be habit-forming or addictive, especially a narcotic.

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.

To spread from one part of the body to another. When cancer cells metastasize and form secondary tumors, the cells in the metastatic tumor are like those in the original (primary) tumor.

A group of lung cancers that are named for the kinds of cells found in the cancer and how the cells look under a microscope. The three main types of non-small cell lung cancer are squamous cell carcinoma, large cell carcinoma, and adenocarcinoma. Non-small cell lung cancer is the most common kind of lung cancer.

Cancer that forms in tissues of the ovary (one of a pair of female reproductive glands in which the ova, or eggs, are formed). Most ovarian cancers are either ovarian epithelial carcinomas (cancer that begins in the cells on the surface of the ovary) or malignant germ cell tumors (cancer that begins in egg cells).

A disease in which malignant (cancer) cells are found in the tissues of the pancreas. Also called exocrine cancer.

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