Cancer Clinical Trials Information

Back to top

What Is a Clinical Trial?

A clinical trial is a study that uses humans to test the safety and effectiveness of a new drug or medical procedure. Clinical trials also test the safety and effectiveness of new methods that help prevent, detect, diagnose, or determine the extent of a disease.

Not all clinical trials test new drugs, procedures and methods; many trials test the safety and effectiveness of existing drugs, procedures and methods. Clinical trials also help doctors determine if existing treatments, procedures and methods can be used in different ways or for other diseases. For instance, cancer clinical trials may test existing cancer drugs to determine if they are safe and effective in treating multiple types of cancer.

Back to top

Who Can Participate in a Cancer Clinical Trial?

Every cancer clinical trial is different and has different eligibility criteria, or conditions that must be met. To determine if you qualify for a clinical trial, the trial research coordinator often considers the following:

  • The type of cancer you have
  • The stage of your cancer (how advanced it is)
  • If you have had previous cancer treatments
  • How long it has been since your last cancer treatment
  • Laboratory test results
  • Current medications
  • History of cancer and other medical conditions
  • Activity level (also called performance status )
  • Gender and age
  • Other conditions specific to the clinical trial
Back to top

Is a Cancer Clinical Trial Right for Me?

Participating in a cancer clinical trial can be a very difficult decision. Your doctor can help you determine if a clinical trial may be right for you. You need to consider the risks and benefits of the clinical trial, cost issues, how the length of the trial may affect you and your loved ones, your expectations of the trial, and other factors.

You also may want to talk to family and friends about your interest in a clinical trial. While you are the one who makes the final decision, it may be helpful to hear the opinions and concerns of your loved ones.

If you decide a clinical trial is right for you, contact the clinical trial research coordinator or principal investigator to learn more about the clinical trial and eligibility criteria.

Back to top

Who Conducts Cancer Clinical Trials, and Who Pays for Them?

Cooperative groups (networks of U.S. institutions and doctors specializing in cancer) usually conduct cancer clinical trials, and researchers (usually doctors) lead the clinical trials. These researchers are called principal investigators. The main cooperative groups conducting clinical trials in the United States include the following:

  • American College of Radiology Imaging Network (ACRIN)
  • American College of Surgeons Oncology Group (ACOSOG)
  • Cancer and Leukemia Group B (CALGB)
  • Children's Oncology Group (COG)
  • Eastern Cooperative Oncology Group (ECOG)
  • Gynecologic Oncology Group (GOG)
  • National Surgical Adjuvant Breast and Bowel Project (NSABP)
  • North Central Cancer Treatment Group (NCCTG)
  • Radiation Therapy Oncology Group (RTOG)
  • Southwest Oncology Group (SWOG)
  • National Cancer Institute (NCI)

The government organization called the National Cancer Institute sponsors, or pays for, a large number of cancer clinical trials in the United States. Other sponsors include pharmaceutical companies, other government organizations, and nonprofit organizations.

Your insurance company may cover certain portions of cancer clinical trial costs, but every insurance company is different. It is important for you and your doctor to discuss clinical trial costs with the study sponsor and your insurance company.

Back to top

How Can I Learn More About Cancer Clinical Trials?

To learn more about cancer clinical trials, contact the American Cancer Society at 800-ACS-2435 (www.cancer.org) or the National Cancer Institute at 800-4 CANCER (www.cancer.gov).

If you are interested in getting help finding a cancer clinical trial that may be right for you, consider contacting one of the following organizations offering clinical trial matching services:



IMPORTANT SAFETY INFORMATION

WARNING: Taxotere® treatment can cause serious, physically limiting, and potentially life-threatening side effects, such as infection, low blood-cell counts, allergic reaction, and retention of excess fluid (edema).

Taxotere® should not be given to patients with low white–blood-cell counts, abnormal liver function, or a history of allergic reactions to Taxotere® or any of the ingredients in Taxotere®.

Before each Taxotere® treatment, all patients treated with Taxotere® must receive another medicine called dexamethasone. This drug can help reduce the risk of fluid retention (edema) and allergic reactions.

Taxotere® should be administered only under the supervision of a qualified physician experienced in the use of anticancer treatments. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

Treatment-related acute myeloid leukemia (AML) or myelodysplasia has occurred in patients given anthracyclines and/or cyclophosphamide, including use with Taxotere® in adjuvant therapy for breast cancer.

The most common severe side effects are low white–blood-cell count, anemia, fatigue, diarrhea, and mouth and throat irritation. Low white–blood-cell count can lead to life-threatening infections. The earliest sign of infection may be fever, so tell your doctor right away if you have a fever.

Other common side effects from Taxotere® include nausea, vomiting, hair loss, rash, infusion-site reactions, odd sensations (such as numbness, tingling, or burning) or weakness in the hands and feet, nail changes, muscle and/or bone pain, or excessive tearing.

Because of the potential risk of fetal harm, pregnant women should not receive Taxotere®. Women of childbearing potential should avoid becoming pregnant during treatment with Taxotere®.

Before receiving Taxotere®, tell your doctor if

  • You have any allergies
  • You are taking any other medicines — including nonprescription (over-the-counter) drugs, vitamins, and dietary or herbal supplements

When taking Taxotere®, contact your doctor if

  • You have symptoms of an allergic reaction (warm sensation, tightness in your chest, itching/hives, or shortness of breath)
  • You experience any other side effects

Please see accompanying full prescribing information, including boxed WARNING.

Click here for information on drug anti-counterfeiting.

Taxotere® (docetaxel) Injection Concentrate Indications

Breast Cancer
TAXOTERE® is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy
TAXOTERE® in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer

Non-Small Cell Lung Cancer
TAXOTERE®, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy
TAXOTERE® in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic NSCLC who have not previously received chemotherapy for this condition.

Prostate Cancer
TAXOTERE® in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.

Gastric Cancer
TAXOTERE® in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.

Head and Neck Cancer
TAXOTERE® in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).