The Hux Cancer Center participates in clinical trials for the prevention, diagnosis and treatment of cancer. All of the trials currently enrolling patients are sponsored by national cooperative oncology groups or are sponsored by pharmaceutical companies.

Clinical trials allow the Hux Cancer Center oncologists to offer our patients the latest in cancer treatment right here in the Wabash Valley. This section of the Hux Cancer Center web page will offer information about clinical trials, what they are, which trials are available and how you can take part.

What is a clinical trial?

A clinical trial is a study conducted with cancer patients to evaluate a new treatment. Studies are designed to answer specific questions and to find new ways to treat cancer patients. Not all trials involve new drugs. Sometimes putting old drugs together in a new way may provide a better way to treat cancer. In order to determine if that is the case a clinical trial would need to be done. This trial would test the new combination of drugs against what had previously been considered a standard of care. Clinical trials are done using a "protocol." If everyone participating in the clinical trial is treated in exactly the same way, when the trial is completed the question being asked (e.g., which drug is better) may be able to be answered. If different doctors treated patients in different ways at the end of the study the data would be so jumbled that no one could determine whether the treatment was working or not. A clinical trial uses a "protocol" to standardize treatment. The protocol is like a cookbook that sets out exactly how, when, with what dose, with what dose modifications, etc. each patient will be treated. In this way, every patient is treated exactly the same no matter where in the country they are entered into the clinical trial.

The hardest thing for patients to understand about a clinical trial is that it is often randomized. This means that someone else will choose which type of treatment the patient will receive. Usually equal numbers of patients will receive each of the different types of treatment that are being evaluated. At the end of the study there will be a comparison between the treatments to see if one is better. The "new" treatment is not always better than the old.

A good example of this is bone marrow transplant in breast cancer. Most women (and their doctors) felt that transplant had a better chance of curing breast cancer than standard chemotherapy and they refused to be in a trial for fear of being in the group that received only chemotherapy. It took a very long time to get enough women into trials comparing the two treatments. We now know that standard chemotherapy is as good or better than bone marrow transplant for breast cancer patients. If women weren't willing to be randomly placed into the two study arms, we would still be doing bone marrow transplants for women with breast cancer and actually giving inferior treatment.

There are 3 types of clinical trials:

• Phase I trials are studies of drugs that have been found in the laboratory to possibly have an effect against cancer. Investigators know what the effects of the drug are in animals but not in humans. In a Phase I trial patients who have advanced cancer volunteer to take the new drug to determine what its effects will be in humans. The goal of the study is to find out if the drug can be safely given to humans. A favorable effect on the cancer that the patient has is an added benefit but not a goal of the study. The investigational drug is usually given to just a few people, oftentimes 3 or 4, at a given dose. If that dose proves safe then the dose is escalated in another 3 or 4 people. The study is usually continued until intolerable side effects occur in the final 3 or 4 people.
  
• When a drug has been found in a Phase I study to be safe for administration to humans the drug is then given to a group of patients with a specific type of cancer in a Phase II trial. For example 30 people with lung cancer might be given a new drug to determine if it has any effect in lung cancer. The type of cancer that is chosen for study may be suggested by the response of patients during the Phase I study or the drug may be used in all types of cancer where there is no effective therapy available. Usually the patients in a Phase II study have had progression of their cancer and received 1 or 2 forms of standard therapy already.
  
• Phase III studies are done to evaluate drugs that have shown some benefit in Phase II trials. It is now known that the drug has a definite effect against a certain type of cancer. The new drug is now tried in patients who oftentimes have not previously received standard therapy. Usually a standard treatment is compared against the investigational drug to see if the new drug is better than the previous best therapy.

Once a drug has shown definite benefit in a Phase III study it would be evaluated by the F.D.A. for possible release for general use. If the drug has shown definite benefit then the F.D.A. will allow cancer doctors to use it for treatment of all patients whose cancers may to possibly respond to the new drug.

Clinical trials do not necessarily provide a definite benefit for those who participate in them. In Phase I and Phase II trials the patient oftentimes will not benefit from the new treatment; that is why patients in Phase I and Phase II trials usually have diseases that no longer respond to standard treatment. Clinical trials do offer hope for potential benefit. There is hope for curing the disease but it is uncommon that a new drug will provide a cure. New drugs may provide an improved quality of life and perhaps an increase in the length of life. Clinical trials certainly offer the possibility of helping others in the future since it is only by studying drugs that new treatments are developed. Clinical trials are carefully monitored to be sure that the new treatment it is not worse than a previous treatment. Clinical trials are monitored closely to be sure that there are no untoward risks occurring so that patients will not continue to be entered into a trial unnecessarily. All clinical trials are reviewed by an Institutional Review Committee to be sure that ethical guidelines are being followed and that the consent forms for each of the clinical trials fully explain the potential risks and benefits of participation.

From the above discussion it should be clear that clinical trials all entail some form of risk. In Phase I trials the risk it is greatest since this it is a study to determine a safe dose; this implies that some patients will get a dose that may cause side effects. All drugs have some potential risk of side effects. As mentioned above patients in clinical trials are followed very closely to ascertain if they are having side effects so that drug dosages may be changed or the trial may be stopped early if significant problems are occurring. Doctors try to limit the side effects of the treatment in a number of ways. Clinical trials usually have very stringent requirements for minimizing risk to patients.

Not everyone it is eligible for a clinical trial. Each trial it is designed to answer a set of research questions regarding a particular disease. Usually the requirements for entering into a clinical study are fairly stringent to be sure that the population studied will be quite uniform. Having a uniform study group will ensure that at the end of the trial there it is a good chance of answering the original question.

Participating in a clinical trial usually requires some extra time of the participants.
Usually the participants will have more and perhaps more expensive follow-up studies than they would if they were not participants in the trial. The National Cancer Institute suggests the participant consider the following questions before entering a clinical trial:

What it is the purpose of the study?
What does the study involve?
What kinds of tests and treatments will be done?
What it is likely to happen in my case with or without the new research treatment?
What are the other choices and their advantages and disadvantages?
How could the study affect my daily life?
What side effects could I expect from the study and will they be different from the standard treatment or the disease itself?
How long will the study last? Will I have to spend extra time to participate in the trial?
Will I have to be hospitalized and if so how often and for how long?
Will there be any cost to the treatment?
Will the cost be more than standard treatment?
Will any of the treatment be free?
If I am harmed as a result of the research what treatment will I be entitled to?
What type of long-term follow-up care it is part of the study?

As mentioned above patients who enter a clinical trial will be asked to sign an informed consent document. This document usually will set out all of the potential risks and benefits of the trial and describe in some way the patient's rights and responsibilities as a participant. Signing the consent document indicates that the patient understands all of the risks and benefits of the trial. Usually patients are allowed to stop participation in the trial at any time. In some cases patients may be asked to leave the trial or the trial may be closed early if unusual side effects are occurring.

This web site lists all of the clinical trials that are currently active at the Hux Cancer Center. Additional information regarding clinical trials can be obtained from the National Institutes of Health or the National Cancer Institute web pages.

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