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Clinical Trials and Emerging Research
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Clinical trials are carefully controlled research studies that test new treatments in people with cancer before they are approved for widespread use. This research forms the foundation for medical advances leading to improved cancer treatments. Nearly all standard treatments started in clinical trials and emerged as a "gold standard" only after proving to be more beneficial than the previous standard.
Research studies offer patients at any stage of cancer an additional treatment option. Many patients with common cancers choose to participate in a clinical trial to take advantage of promising new treatments that may one day prove to be superior to the current standard.
Colorectal cancer research
A new line of medications called angiogenesis inhibitors or antiangiogenic agents are being developed and studied with great interest. Cancerous tumors are able to grow only if they have an adequate blood supply. A naturally occurring protein called Vascular Endothelial Growth Factor (VEGF) has long been know as an angiogenic agent and plays an important role in colon cancer's ability to grow its own blood supply (angiogenesis). Cancer needs a blood supply to grow and metastasize to other areas of the body. The hope is that antiangiogenic agents will block the action of VEGF and stop the tumor's ability to grow its own blood supply.
In May 2003 an antiangiogenesis agent called bevacizumab (Avastin™) received recognition from the Food and Drug Administration (FDA) and was placed into a Fast Track development program. This was done because promising results from clinical trials showed that overall survival of patients with metastatic cancer improved by more than 4 months when bevacizumab (Avastin™) was given in combination with standard chemotherapy rather than standard chemotherapy alone. In February 2004, bevecizumab (Avastin ™) was approved by the Food and Drug Administration (FDA) for first line (initial) treatment for metastatic colorectal cancer. It is used in combination with standard chemotherapy. Cetuximab (Erbitux™) was approved by the Food and Drug Administration in February 2004 for treatment of metastatic colon cancer to be used in combination with irinotecan. Antiangiogenesis agents are showing promise in the treatment of colorectal cancer and continue to be studied in clinical trials in combination with standard chemotherapy drugs.
Participants in clinical trials understand that, like anything new, a clinical trial also carries the risk that the treatment may not result in an improved outcome. These patients know that regardless of the final result, their participation contributes to research that leads to better treatment for future patients.
Clinical trials investigate many types of approaches such as new drugs, new devices, new surgical or radiation procedures, new modes of therapy such as biologic therapy, and new ways to reduce the side effects of treatment.
Here are some points to consider in deciding whether to participate in a clinical trial:
- Participating in a clinical trial is always voluntary, however, each patient who desires to participate must meet strict eligibility criteria for a particular study before he or she can be included.
- Once eligibility requirements are met, doctors and nurses must explain the details of the study to patients before they enroll. Patients should know if the research treatment has been used with other kinds of cancers and how successful it has been. It is important to understand how doctors think your disease will progress both with and without the treatment being studied.
- Patients need to have a clear understanding of other treatment options (both standard and research treatments) including their risks, benefits, side effects, and what outcomes they can expect.
- Participants should be aware of available therapies to manage unpleasant or serious reactions. Although many side effects can disappear during treatment, some may be long-lasting or permanent. Some side effects may be life threatening. Remember, standard cancer treatments also have side effects.
- Patients should ask whether they must pay for the treatment, follow-up, and any related costs (for example, transportation and lodging). Many trials, particularly those sponsored by drug or medical device companies, may provide some or all of the treatment at no cost to participants.
- Participation in a clinical trial does not necessarily mean the patient will receive the new treatment. Often half the patients in a clinical trial receive a standard treatment so researchers can accurately compare the new treatment to the standard.
After learning about a study and having a chance to ask questions, patients who wish to participate must give their permission in writing. This permission is called an informed consent and is required by law. The informed consent form describes what will be involved in participating in a clinical trial, the tests and treatments they will receive, how it will affect their daily lives and the possible risks and benefits. This form should be carefully reviewed face-to-face with someone involved in the clinical trial and with your doctor for clarification of any parts of the trial that need further explanation.
Even after enrolling, participants can leave a study at any time they feel it is no longer in their best interests to participate.
Clinical trials normally include three steps or phases
Before a new treatment or drug is approved for widespread use, the U.S. Food and Drug Administration (FDA), requires researchers to prove the new treatment is safe and effective through three phases of clinical trials. The FDA requires a different type of study for each phase. Patients normally participate in only one phase of a clinical trial. When all phases are completed, researchers present the results of all three phases to the FDA for approval.
Phase I Studies: Safety
Phase I trials involve a small number of people perhaps fewer than a dozen. They are designed to determine the specifics about administering a drug or treatment regimen. Researchers determine how the treatment should be given, for example, intravenously, or by mouth, how often it should be given, and what is the optimal dose.
Phase II Studies: Safety and Effectiveness
This step is to determine whether a new treatment is likely to be effective. Doctors continue to carefully watch for side effects from treatment during this phase.
Phase III Studies: Safety and Effectiveness in Many Patients
Phase III studies compare the effectiveness of the new treatment with the generally accepted treatment (standard treatment) for the type of cancer being studied. To do this, they assign some of the study patients to a "control" group. Control group patients receive the standard cancer treatment. Other participants get the research treatment.
There are many things to consider when making a decision to participate in a clinical trial. Talking to your doctor will help clear up any concerns you may have. Only you, together with your family, and your doctor can decide whether participating in a clinical trial is appropriate for you.
For further information, check these resources to find out about current clinical trials under way for colorectal cancer:
- National Cancer Institute clinical trials web page, at http://www.cancer.gov/clinicaltrials
or the Cancer Information Service (CIS) at 1-800-4-CANCER
- ClinicalTrials.gov, a registry developed at the National Institutes of Health (NIH) by the National Library of Medicine at http://clinicaltrials.gov
- American Cancer Society at 1-800-ACS-2345
- CenterWatch Clinical Trials Listing Service at www.centerwatch.com
Content courtesy of NexCura© 2005, from the NexProfiler™ Tool for Colorectal Cancer.
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